QA Leader II: Compliance, CI & Regulatory Impact

EPM Scientific; Morristown (TN); On-site; USD 120,000 - 180,000; Full time

Job summary

EPM Scientific is seeking an experienced Quality Assurance Manager II to lead QA, QC, and QA Engineering at a state-of-the-art Tennessee site. This leadership role partners with Operations, Engineering, Product Development, and Corporate Quality to ensure regulatory compliance and drive continuous improvement.

The ideal candidate has 10+ years in quality leadership within FDA-regulated manufacturing, strong CAPA/RCA skills, and a track record of building high-performing quality teams to support

Qualifications

• Bachelor's degree in a scientific, engineering, or technical discipline.
• 10+ years of quality leadership in an FDA-regulated manufacturing environment.
• Experience leading QA, QC, and/or QA Engineering teams.
• Strong knowledge of FDA regulations (21 CFR Parts 11, 210, 211, 820); ISO 13485; cGMP; QMS; CAPA; RCA; risk management.

Responsibilities

• Lead QA, QC, and QA Engineering activities across the site.
• Oversee investigations, deviations, nonconforming materials, CAPAs, and quality system processes.
• Drive continuous improvement initiatives focused on product quality, compliance, and operational performance.
• Ensure compliance with FDA regulations, cGMP requirements, and internal quality management systems.
• Lead internal audits, customer audits, and regulatory inspections.
• Collaborate with suppliers, customers, and cross-functional stakeholders on quality-related initiatives.
• Support new product introductions, process validation programs, and risk management activities.
• Develop, mentor, and lead a high-performing quality organization.

Skills

Quality leadership

Cross-functional collaboration

Regulatory compliance

Quality systems knowledge

Education

Bachelor's degree in a scientific/engineering/technical discipline

Job description

EPM Scientific is seeking an experienced Quality Assurance Manager II to lead QA, QC, and QA Engineering at a state-of-the-art Tennessee site. This leadership role partners with Operations, Engineering, Product Development, and Corporate Quality to ensure regulatory compliance and drive continuous improvement.

The ideal candidate has 10+ years in quality leadership within FDA-regulated manufacturing, strong CAPA/RCA skills, and a track record of building high-performing quality teams to support