QA Manager

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.