Adv. Manufacturing

***Minimum Experience Required*** Job Type: Full-Time | Day Shift | In-Person Location: 120 Glassmaster Road, Lexington, SC 29072 Schedule: 40 hours per week | Monday-Friday, 8am-5pm with a 1-hour lunch break Pay: From $16.00 per hour Who we are: Sorinex Exercise Equipment, based in Lexington, SC, is a leader in fitness equipment manufacturing and innovation. For over 40 years, we’ve built the highest-quality gym and strength training equipment for home gyms, college athletics, professional sports teams, and the U.S. military. As we continue to grow, we’re hiring motivated individuals to join our team through our direct hire opportunities with long-term growth potential. If you’re looking for a career to grow and excel, apply now! Who we are looking for: We are seeking a reliable and motivated Warehouse Prep Employee to join our Powder Coating department. This position plays a key role in ensuring high-quality finishes on all metal products. Previous experience with powder coating, painting, or industrial finishing is a plus — however, on-the-job training will be provided for the right candidate. We are looking for someone who can: Prepare, clean, and hang metal parts on the automated powder coating line. Inspect welded products for imperfections, weld BBs, and surface defects before coating. Monitor parts throughout the powder coating process to ensure consistent quality and finish. Apply powder coating techniques following standard procedures and safety guidelines. Assist with color changes and powder management to maintain production efficiency. Continuously inspect coated parts for uniform coverage, adhesion, and finish quality. Perform routine maintenance and cleaning of equipment and tools. Maintain a clean, organized, and safe work environment at all times. Follow all company safety, quality, and documentation procedures. Perform all other duties as assigned Physical Demands: Lift, carry, push, and/or pull 1-50 lbs. frequently Squat/kneel, bend/stoop, crawl, twist/turn, grasp, and reach overhead and outward frequently Sit, stand, and walk for 1-10 hours per day Work in a fast-paced industrial environment wearing hearing protection, eye protection, steel-toed shoes, and other appropriate protective clothing Benefits: 401(k) 401(k) Matching Dental Insurance Health Insurance Life insurance Paid time off Vision insurance

Job Type: Full-Time | Day Shift | In-Person Location: 193 Litton Drive, Lexington, SC 29073 Schedule: 40 hours per week | Monday-Friday, 8am-5pm with a 1-hour lunch break Pay: From $16.00 per hour Who we are: Sorinex Exercise Equipment, based in Lexington, SC, is a leader in fitness equipment manufacturing and innovation. For over 40 years, we’ve built the highest-quality gym and strength training equipment for home gyms, college athletics, professional sports teams, and the U.S. military. As we continue to grow, we’re hiring motivated individuals to join our team through direct-hire opportunities with long-term career potential. If you’re looking for a career where you can grow and excel, apply now! Who we are looking for: Sorinex is seeking a skilled and motivated individual to work in our print shop (merchandise department). This position is focused on fast-paced production and fulfillment centered around apparel items. This position’s primary functions will be to manage inventory of various products Sorinex utilizes for web sales and marketing events. The finished product will then need to be packed and staged for shipping to our customers. Manage the full screen printing process, including setup, operation, and maintenance of manual and automated presses Oversee inventory tasks such as folding, counting, and organizing finished goods Perform routine preventative maintenance on printing and production equipment to ensure optimal performance Troubleshoot production issues and maintain high standards of quality control throughout the process Meet or exceed established production output goals for the department Support order fulfillment by accurately packaging, labeling, and preparing products for shipment Assist with general upkeep of the print shop, including cleaning and organizing work areas Perform other related duties as assigned to support the printing and fulfillment team Physical Demands: Lift, carry, push, and/or pull 1-50 lbs. frequently Squat/kneel, bend/stoop, crawl, twist/turn, grasp, and reach overhead and outward frequently Sit, stand, and walk for 1-10 hours per day Work in a fast-paced industrial environment wearing hearing protection, eye protection, and other appropriate protective clothing as required Benefits: 401(k) 401(k) Matching Dental Insurance Health Insurance Life insurance Paid time off Vision insurance Required Licenses/Education/Experience: Valid state-issued Driver’s License (preferred) High School Diploma (preferred) T-Shirt Printing: 2 years

Job Type: Full-Time | Day Shift | In-Person Location: 120 Glassmaster Road, Lexington, SC 29072 Schedule: 40 hours per week | Monday-Friday, 8am-5pm with a 1-hour lunch break Pay: From $17.00 per hour Who we are: Sorinex Exercise Equipment, based in Lexington, SC, is a leader in fitness equipment manufacturing and innovation. For over 40 years, we’ve built the highest-quality gym and strength training equipment for home gyms, college athletics, professional sports teams, and the U.S. military. As we continue to grow, we’re hiring motivated individuals to join our team through direct-hire opportunities with long-term career potential. If you’re looking for a career where you can grow and excel, apply now! Who we are looking for: We are seeking a reliable Warehouse Assembler to join our production and assembly team. The ideal candidate will have strong attention to detail and experience working with hand tools, power tools, or in a warehouse, manufacturing, or assembly environment. You will be responsible for assembling products according to specifications, performing quality checks, and helping meet production goals in a clean and organized workspace. We are looking for someone who can: Sort, count, and organize parts and materials before assembly Assemble products using hand and power tools according to work instructions Read and interpret blueprints, diagrams, or assembly instructions accurately Perform visual and manual quality inspections on finished products to ensure they meet specifications Maintain a clean, safe, and orderly work area in the warehouse and assembly station Work on routine assembly tasks with consistency and precision Identify and resolve basic assembly issues, reporting mechanical or production issues to supervisors Communicate clearly with supervisors and team members regarding workflow and tasks Support overall warehouse operations and cross-train as needed Perform all other duties as assigned Physical Demands: Lift, carry, push, and/or pull 1-50 lbs. frequently Squat/kneel, bend/stoop, crawl, twist/turn, grasp, and reach overhead and outward frequently Sit, stand, and walk for 1-10 hours per day Work in a fast-paced industrial environment wearing hearing protection, eye protection, steel-toed shoes, and other appropriate protective clothing Required Experience: Manufacturing: 2 years Assembly: 2 years Benefits: 401(k) 401(k) Matching Dental Insurance Health Insurance Life insurance Paid time off Vision insurance

Description: Job Type: Full-Time | Day Shift | In-Person Location: 120 Glassmaster Road, Lexington, SC 29072 Schedule: 40 hours per week | Monday-Friday, 8am-5pm with a 1-hour lunch break Pay: From $17.00 per hour Who we are: Sorinex Exercise Equipment, based in Lexington, SC, is a leader in fitness equipment manufacturing and innovation. For over 40 years, we’ve built the highest-quality gym and strength training equipment for home gyms, college athletics, professional sports teams, and the U.S. military. As we continue to grow, we’re hiring motivated individuals to join our team through direct-hire opportunities with long-term career potential. If you’re looking for a career where you can grow and excel, apply now! Who we are looking for: We are seeking a reliable Warehouse Assembler to join our production and assembly team. The ideal candidate will have strong attention to detail and experience working with hand tools, power tools, or in a warehouse, manufacturing, or assembly environment. You will be responsible for assembling products according to specifications, performing quality checks, and helping meet production goals in a clean and organized workspace. We are looking for someone who can: Sort, count, and organize parts and materials before assembly Assemble products using hand and power tools according to work instructions Read and interpret blueprints, diagrams, or assembly instructions accurately Perform visual and manual quality inspections on finished products to ensure they meet specifications Maintain a clean, safe, and orderly work area in the warehouse and assembly station Work on routine assembly tasks with consistency and precision Identify and resolve basic assembly issues, reporting mechanical or production issues to supervisors Communicate clearly with supervisors and team members regarding workflow and tasks Support overall warehouse operations and cross-train as needed Perform all other duties as assigned Physical Demands: Lift, carry, push, and/or pull 1-50 lbs. frequently Squat/kneel, bend/stoop, crawl, twist/turn, grasp, and reach overhead and outward frequently Sit, stand, and walk for 1-10 hours per day Work in a fast-paced industrial environment wearing hearing protection, eye protection, steel-toed shoes, and other appropriate protective clothing Benefits: 401(k) 401(k) Matching Dental Insurance Health Insurance Life insurance Paid time off Vision insurance Requirements: Experience: Manufacturing: 2 years Assembly: 2 years

Description: Job Type: Full-Time | Evening/Night Shift | In-Person Location: 193 Litton Drive, Lexington, SC 29073 Schedule: 40 hours per week | Monday-Friday, 5pm-1:30am with a 30-minute lunch break Pay: From $20.00 per hour Who we are: Sorinex Exercise Equipment, based in Lexington, SC, is a leader in fitness equipment manufacturing and innovation. For over 40 years, we’ve built the highest-quality gym and strength training equipment for home gyms, college athletics, professional sports teams, and the U.S. military. As we continue to grow, we’re hiring motivated individuals to join our team through direct-hire opportunities with long-term career potential. If you’re looking for a career where you can grow and excel, apply now! Who we are looking for: We are looking for a skilled and detail-oriented CNC Machine Operator to join our growing manufacturing team. In this role, you will set up and operate various CNC machines and lasers to produce high-quality precision parts from a variety of materials. The ideal candidate will have strong technical knowledge, a solid understanding of blueprint reading, and the ability to follow setup sheets and standardized manufacturing processes. We are looking for someone who can: Perform laser cutting operations with precision and efficiency. Choose the appropriate cutting programs to match specific job requirements. Accurately set up equipment for cutting operations. Inspect the quality and dimensions of cuts to meet exact specifications. Load and unload materials, and efficiently sort parts for the next stages of production. Follow standardized work processes, ensuring correct documentation and procedures are maintained. Produce consistently accurate work on a daily basis. Occasionally lift items weighing over 50 pounds. Take verbal direction with minimal assistance and complete tasks efficiently and independently. Read, interpret, and follow blueprints, diagrams, engineering drawings, bills of materials, and other instructions with ease. Maintain a safe, clean, and organized work area at all times. Perform all other duties as assigned. Physical Demands: Lift, carry, push, and/or pull 1-50 lbs. frequently Squat/kneel, bend/stoop, crawl, twist/turn, grasp, and reach overhead and outward frequently Sit, stand, and walk for 1-10 hours per day Work in a fast-paced industrial environment wearing hearing protection, eye protection, steel-toed shoes, and other appropriate protective clothing Benefits: 401(k) 401(k) Matching Dental Insurance Health Insurance Life insurance Paid time off Vision insurance Requirements: Experience: Machining: 2 years CNC Operating: 2 years

***Minimum Experience Required*** Job Type: Full-Time | Day Shift | In-Person Location: 120 Glassmaster Road, Lexington, SC 29072 Schedule: 40 hours per week | Monday-Friday, 8am-5pm with a 1-hour lunch break Pay: From $16.00 per hour Who we are: Sorinex Exercise Equipment, based in Lexington, SC, is a leader in fitness equipment manufacturing and innovation. For over 40 years, we’ve built the highest-quality gym and strength training equipment for home gyms, college athletics, professional sports teams, and the U.S. military. As we continue to grow, we’re hiring motivated individuals to join our team through our direct hire opportunities with long-term growth potential. If you’re looking for a career to grow and excel, apply now! Who we are looking for: We are seeking a reliable and motivated Warehouse Prep Employee to join our Powder Coating department. This position plays a key role in ensuring high-quality finishes on all metal products. Previous experience with powder coating, painting, or industrial finishing is a plus — however, on-the-job training will be provided for the right candidate. We are looking for someone who can: Prepare, clean, and hang metal parts on the automated powder coating line. Inspect welded products for imperfections, weld BBs, and surface defects before coating. Monitor parts throughout the powder coating process to ensure consistent quality and finish. Apply powder coating techniques following standard procedures and safety guidelines. Assist with color changes and powder management to maintain production efficiency. Continuously inspect coated parts for uniform coverage, adhesion, and finish quality. Perform routine maintenance and cleaning of equipment and tools. Maintain a clean, organized, and safe work environment at all times. Follow all company safety, quality, and documentation procedures. Perform all other duties as assigned Physical Demands: Lift, carry, push, and/or pull 1-50 lbs. frequently Squat/kneel, bend/stoop, crawl, twist/turn, grasp, and reach overhead and outward frequently Sit, stand, and walk for 1-10 hours per day Work in a fast-paced industrial environment wearing hearing protection, eye protection, steel-toed shoes, and other appropriate protective clothing Benefits: 401(k) 401(k) Matching Dental Insurance Health Insurance Life insurance Paid time off Vision insurance

Job Purpose: The Production Change Control Manager is responsible for overseeing and managing change control activities related to manufacturing operations, including production processes, equipment, facilities, materials, and associated documentation. This role ensures compliance with FDA regulations, cGMPs, and internal quality systems by evaluating the impact of proposed changes, implementing appropriate controls, and maintaining product quality, safety, and regulatory compliance. The Production Change Control Manager serves as a subject matter expert (SME) for change control within manufacturing and provides guidance to cross-functional teams to ensure changes are properly assessed, documented, approved, and implemented Essential Duties and Responsibilities: Manage and oversee production-related change control activities in accordance with FDA regulations, cGMPs, and company quality policies. Facilitate the review, coordination, and approval of change records related to manufacturing processes, equipment, facilities, materials, utilities, and production systems. Evaluate and facilitate review of proposed production changes to assess potential impact on product quality, process performance, validation status, regulatory filings, and compliance. Ensure all changes are thoroughly documented, including change requests, impact assessments, risk assessments, implementation plans, and effectiveness checks. Ensure change controls are appropriately linked to validation, qualification, calibration, maintenance, and training requirements, as applicable. Review controlled documents (SOPs, batch records, work instructions, forms, and labels) to ensure accuracy, completeness, and compliance with approved production changes. Participate in Change Review Board (CRB) meetings, including presentation of production change metrics, trends, and KPIs. Present quarterly change control trends and performance metrics at Quality Management Review (QMR) meetings. Investigate and resolve issues or delays related to change control approvals by collaborating with cross-functional stakeholders. Monitor the effectiveness of production change implementations and identify opportunities for process improvement. Ensure data integrity, traceability, and accuracy of all change control records. Support manufacturing initiatives, campaigns, and special projects requiring change control oversight. Communicate quality-related risks, issues, or noncompliance related to production changes to Quality Management or designee. Participate in continuous improvement efforts to enhance the efficiency and effectiveness of production change control processes. Perform other duties as assigned or required to support manufacturing and quality objectives. Supplemental Functions: Support and participate in customer, internal, and regulatory audits and inspections, specifically related to production change control. Educate and train manufacturing and support personnel on production change control procedures, documentation standards, and best practices. Conduct system access and change control training for new production and support employees. Periodically review production change control activities and metrics to identify trends, risks, and improvement opportunities. Job Specifications and Qualifications Knowledge & Skills: Strong technical background with solid knowledge of Quality Assurance, cGMPs, FDA regulations, and QMS-based change control systems. Hands-on experience managing production change controls within electronic Quality Management Systems (eQMS). Excellent written and verbal communication skills with strong interpersonal abilities. Strong analytical, critical-thinking, and problem-solving skills, with high attention to detail and data integrity. Ability to manage multiple priorities, meet deadlines, and perform effectively in a fast-paced manufacturing environment. Ability to work independently and collaboratively across cross-functional teams. Proficient in technical writing and use of Microsoft Word, Excel, and Adobe Acrobat. Demonstrates professionalism, integrity, and discretion in handling confidential quality and regulatory information. Education/Experience: · Bachelor’s degree in Engineering, Life Sciences, Chemistry, Biology, or a related technical discipline required. · Advanced degree or Quality/Regulatory certification (e.g., ASQ, CQE, CQA) preferred. · 5+years of experience in a regulated manufacturing environment (pharmaceutical, biotech, medical device, or related industry). · 3+ years of hands-on experience managing change control within a QMS or electronic QMS (eQMS). · Demonstrated experience evaluating changes to manufacturing processes, equipment, facilities, utilities, and materials. · Working knowledge of cGMP, FDA regulations, and quality systems governing production operations. · Experience supporting regulatory inspections, customer audits, and internal audits. · Proven ability to collaborate with Manufacturing, Engineering, Validation, Maintenance, and Quality teams. · Experience leading or participating in Change Review Boards (CRB) and presenting change control metrics or KPIs preferred. Working Conditions / Physical Requirements: This position requires bending, typing, lifting (up to 40 1bs.), standing, sitting and walking throughout the facility. Willingness to change direction and focus to meet shifting organizational and business demands. Individual may require to wear specified protective equipment if necessary Hours of work: Monday thru Friday on 8 hours shift, or as needed based on company demand.

Hungry for a career that’s as rewarding as it is delicious? At Aspire Bakeries, we don’t just bake breads, cookies, and cakes - we create foods that bring people together. From La Brea Bakery® artisan breads to Otis Spunkmeyer® cookies, our products are enjoyed by millions of people every day. And behind every bite are talented manufacturing and support teams who take pride in their work and our food. We’re looking for hard-working people who will bring integrity, creativity, and a passion for excellence to everything they do - whether that’s on the bakery floor, in the office, or supporting customers. In return, we offer a workplace culture built on care, ownership, and growth - where your contributions matter and your career can rise as high as our bread loaves! With 13 commercial bakeries across North America and a reputation as an industry leader, Aspire Bakeries is rising together with our people and our customers to be the best all-around bakery solution. If you’re ready to grow with us, we’d love to hear from you. Why You’ll Love Working At Aspire Bakeries Culture – Our culture thrives on collaboration, diversity, and a shared passion for excellence. We support team members, empower growth, and encourage everyone to bring their authentic selves to work. Health & Wellness – Comprehensive medical, dental, and vision coverage, plus company-paid life insurance and additional voluntary options to fit your needs. Work-Life Balance – Paid parental leave, generous paid time off, and holidays so you can recharge and spend time on what matters most. Financial Security – Competitive retirement plans, plus short- and long-term disability coverage for peace of mind. Growth & Development – Opportunities to build skills, grow your career, and develop expertise through Aspire Bakeries’ learning and development programs. Flexibility & Support – HSA and FSA plans to help you manage everyday expenses. Recognition & Rewards – Performance incentive plans that celebrate achievements across sales, bakery performance, and individual contributions. About the Role We are seeking a Production Coordinator – Technical Focus to join our team at our Cayce bakery. This role combines production coordination with technical responsibilities to ensure reliable operations, minimize downtime, and optimize operator development and preventive maintenance compliance. Shift & Schedule Shift: 2nd Shift Hours: 1:45PM – 10:15PM Weekend Availability: Required Core Accountabilities (What You’ll Be Doing) Production Coordination & Documentation Verify staffing levels and ensure all positions are filled. Provide backup coverage for vacant positions during the shift. Oversee machinery, equipment, and personnel during assigned shift. Report directly to Production Supervisor and collaborate with Maintenance Supervisor. Shift-Specific Technical Responsibilities (2nd Shift) Execute basic preventive maintenance tasks alongside maintenance team. Provide hands-on training and mentorship for production operators. Build technical capacity within the production workforce. Document training progress and identify skill development opportunities. Preventive Maintenance & Downtime Prevention (All Shifts) Perform belt tension checks to prevent jams. Inspect sensors, rods, and hoses to prevent failures. Complete mixer door sensor PM to avoid startup delays. Execute preventive maintenance checklists and report potential issues. Technical Troubleshooting & Problem Solving (All Shifts) Diagnose and resolve equipment issues during production. Make real-time adjustments to optimize performance. Document equipment problems and solutions for continuous improvement. Food Safety & Compliance Follow GMPs and food safety regulations at all times. Maintain effective working relationships and a clean work environment. Minimum Qualifications (What You Bring to the Table) High school diploma or GED required. Minimum 3 years of manufacturing experience. Strong mechanical aptitude and troubleshooting skills. Ability to perform basic preventive maintenance tasks. Effective communication and problem-solving skills. Ability to work flexible hours, including early startup support. Physical Requirements Ability to lift up to 50 lbs. Ability to stand and walk for extended periods. Ability to work in varying temperature environments. Ability to perform repetitive motions and use hand tools. Aspire Bakeries is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other legally protected characteristic. We do not use artificial intelligence (AI) tools to screen, assess, or select applicants.

Hungry for a career that’s as rewarding as it is delicious? At Aspire Bakeries, we don’t just bake breads, cookies, and cakes - we create foods that bring people together. From La Brea Bakery® artisan breads to Otis Spunkmeyer® cookies, our products are enjoyed by millions of people every day. And behind every bite are talented manufacturing and support teams who take pride in their work and our food. We’re looking for hard-working people who will bring integrity, creativity, and a passion for excellence to everything they do - whether that’s on the bakery floor, in the office, or supporting customers. In return, we offer a workplace culture built on care, ownership, and growth - where your contributions matter and your career can rise as high as our bread loaves! With 13 commercial bakeries across North America and a reputation as an industry leader, Aspire Bakeries is rising together with our people and our customers to be the best all-around bakery solution. If you’re ready to grow with us, we’d love to hear from you. Why You’ll Love Working At Aspire Bakeries Culture – Our culture thrives on collaboration, diversity, and a shared passion for excellence. We support team members, empower growth, and encourage everyone to bring their authentic selves to work. Health & Wellness – Comprehensive medical, dental, and vision coverage, plus company-paid life insurance and additional voluntary options to fit your needs. Work-Life Balance – Paid parental leave, generous paid time off, and holidays so you can recharge and spend time on what matters most. Financial Security – Competitive retirement plans, plus short- and long-term disability coverage for peace of mind. Growth & Development – Opportunities to build skills, grow your career, and develop expertise through Aspire Bakeries’ learning and development programs. Flexibility & Support – HSA and FSA plans to help you manage everyday expenses. Recognition & Rewards – Performance incentive plans that celebrate achievements across sales, bakery performance, and individual contributions. About the Role We are seeking a Production Coordinator – Technical Focus to join our team at our Cayce bakery. This role combines production coordination with technical responsibilities to ensure reliable operations, minimize downtime, and optimize startup performance during critical ramp-up periods. Shift & Schedule Shift: 1st Shift Hours: 5:45AM – 2:15PM Weekend Availability: Required Core Accountabilities (What You’ll Be Doing) Production Coordination & Documentation Verify staffing levels and ensure all positions are filled. Provide backup coverage for vacant positions during the shift. Oversee machinery, equipment, and personnel during assigned shift. Report directly to Production Supervisor and collaborate with Maintenance Supervisor. Shift-Specific Technical Responsibilities (1st Shift) Partner with maintenance during 4:00 AM startup operations. Troubleshoot equipment issues during critical ramp-up period. Support startup core team to improve time-to-production metrics. Optimize startup productivity through technical intervention. Address real-time equipment issues as production ramps up. Coordinate with maintenance to resolve mechanical problems quickly. Preventive Maintenance & Downtime Prevention (All Shifts) Perform belt tension checks to prevent jams. Inspect sensors, rods, and hoses to prevent failures. Complete mixer door sensor PM to avoid startup delays. Execute preventive maintenance checklists and report potential issues. Technical Troubleshooting & Problem Solving (All Shifts) Diagnose and resolve equipment issues during production. Make real-time adjustments to optimize performance. Document equipment problems and solutions for continuous improvement. Food Safety & Compliance Follow GMPs and food safety regulations at all times. Maintain effective working relationships and a clean work environment. Minimum Qualifications (What You Bring to the Table) High school diploma or GED required. Minimum 3 years of manufacturing experience. Strong mechanical aptitude and troubleshooting skills. Ability to perform basic preventive maintenance tasks. Effective communication and problem-solving skills. Ability to work flexible hours, including early startup support. Physical Requirements Ability to lift up to 50 lbs. Ability to stand and walk for extended periods. Ability to work in varying temperature environments. Ability to perform repetitive motions and use hand tools. Aspire Bakeries is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other legally protected characteristic. We do not use artificial intelligence (AI) tools to screen, assess, or select applicants.

Corporate Statement Nephron Nitrile is a new privately-owned Nitrile Glove manufacturer. Nephron Nitrile products are proudly made in the USA! We are headquartered in West Columbia, South Carolina. The facility utilizes completely automated manufacturing, packaging, and distribution systems, in addition to high volume and redundant utility systems, to ensure production system availability. Position Summary The QA Manager will lead Quality Assurance execution for Nephron Nitrile medical device manufacturing operations. This role is responsible for ensuring compliance with the Nephron Nitrile Quality Management System and all applicable regulations including 21 CFR 820, ISO 13485:2016, and ISO 14971:2019. This is a hands-on leadership role focused on Quality Assurance while supporting other teams during a scale up manufacturing environment. The QA Manager partners closely with Quality Control (QC) and Quality Engineering (QE) teams to ensure effective quality gate governance and continuous improvement. We are undergoing a major quality transformation — shifting to a prevention-led operating system built on strong processes, credible measurements, and disciplined leadership. This role is about building trust, driving execution, and creating systems that win consistently. Primary Accountabilities Own lot release governance and final product disposition Lead batch record review and QA decision-making Manage and govern the overall quality gate process (supplier, incoming, in-process, compounding, final release) Support and guide QC leaders on inspection strategy, sampling, and escalation decisions Partner with QE to strengthen upstream controls and reduce escapes Oversee QA procedures, records, and compliance documentation Own CAPA system effectiveness and NCR management Lead internal audits and support FDA/ISO audits Champion cGMP and quality best practices on site Lead risk management activities (FMEAs, hazard analysis) in collaboration with engineering Support calibration and metrology governance (through QC/Lab teams) Serve as escalation point for quality decisions Partner cross-functionally across Operations, Supply Chain, and Engineering Knowledge, Skills & Abilities Bachelor’s or master’s degree in engineering, Life Sciences, Chemistry, or related field 10+ years in medical device or regulated manufacturing environment 5+ years in quality leadership roles Experience with disposable medical devices strongly preferred Strong knowledge of 21 CFR 820, ISO 13485, ISO 14971 Demonstrated experience in design controls and risk management Expertise in process & product validation, SPC, and statistic Strong written and verbal communication skills High integrity, accountability, and adaptability Core Leadership Behaviors Build Trust Through Transparency – Communicate openly, share data, and create visibility to drive confidence and alignment. Serve the Team – Practice servant leadership by removing barriers and developing people. Exercise Managerial Courage – Make tough decisions, hold standards, and speak up when quality is at risk. Think Systemically – Fix processes, not symptoms, address root causes upstream. Act Decisively – Contain issues quickly and accelerate learning cycles. Drive Repeatable Execution – Standardize work using lean, scalable processes. Deliver Value – Identify actionable opportunities to reduce risk, cost, and waste. Win Consistently – Build sustainable systems that produce predictable results. Why Join Nephron Nitrile Play a critical role in rebuilding domestic PPE manufacturing Direct impact on patient and clinician safety Work closely with executive leadership High-visibility role with growth opportunity Apply Today If you are ready to lead with courage and build systems that win consistently, we want to hear from you.