QA Manager II

Rockline Industries, people who make it right; Morristown (TN); On-site; USD 110,000 - 160,000; Full time

Job summary

Iatric Manufacturing is seeking an experienced Quality Assurance Manager II to lead the Quality Assurance, Quality Control, and Quality Engineering teams in a FDA-regulated manufacturing environment.

This role partners with Operations, Engineering, Product Development, and Global Quality to drive quality initiatives, improve performance, ensure compliance, and support business growth. Ideal for a strategic quality leader with a passion for continuous improvement.

Qualifications

• 10+ years of QA leadership in FDA-regulated manufacturing.
• Experience leading QA, QC, and QE functions.
• Strong knowledge of FDA 21 CFR Part 11/210/211/820, cGMP, and ISO 13485.

Responsibilities

• Lead all QA, QC, and QE activities to ensure product quality.
• Oversee investigations, deviations, CAPA, and quality systems.
• Drive continuous improvement for quality and regulatory compliance.
• Lead internal/external audits and support inspections.

Skills

Quality leadership

Regulatory compliance

CAPA

Root cause analysis

FDA regulations

Lean manufacturing

Quality systems

Education

Bachelor's degree in science/engineering

Tools

CAPA software

Statistical software

Job description

Full-Time | Exempt | On-Site Lead Quality. Drive Compliance. Make an Impact.

Quality Assurance Manager II

Full-Time | Exempt | On-Site

Iatric Manufacturing | Morristown, TN

Lead Quality. Drive Compliance. Make an Impact.

Iatric Manufacturing is seeking an experienced and strategic Quality Assurance Manager II to lead our Quality Assurance, Quality Control, and Quality Engineering teams in an FDA-regulated manufacturing environment. This role is ideal for a quality leader who is passionate about continuous improvement, regulatory compliance, product safety, and developing high-performing teams.

As a member of the site leadership team, you will partner with Operations, Engineering, Product Development, and Global Quality teams to drive quality initiatives, improve manufacturing performance, ensure regulatory compliance, and support business growth.

What You'll Do

• Lead all Quality Assurance, Quality Control, and Quality Engineering activities.
• Oversee investigations, deviations, nonconforming materials, CAPA, and quality system activities.
• Drive continuous improvement initiatives focused on quality, efficiency, and compliance.
• Ensure compliance with FDA regulations, cGMP requirements, and quality management systems.
• Lead internal and external audits and support regulatory inspections.
• Collaborate with customers, suppliers, and cross-functional teams on quality-related matters.
• Support new product introductions, process validation activities, and risk management initiatives.
• Develop, mentor, and coach quality professionals while fostering a culture of accountability and excellence.
• Lead site quality reviews, strategic planning efforts, and management review activities.

What We're Looking For

Required Qualifications

• Bachelor's degree in Science, Engineering, or a related technical discipline.
• 10+ years of Quality Assurance leadership experience within an FDA-regulated manufacturing environment.
• Experience managing Quality Assurance, Quality Control, and Quality Engineering functions.
• Strong working knowledge of:
• FDA regulations (21 CFR Parts 11, 210, 211, and 820)
• cGMP manufacturing environments
• ISO 13485
• CAPA, Root Cause Analysis, and Risk Management
• Process, Cleaning, Software, and Analytical Method Validation
• Statistical Process Control and Lean Manufacturing principles.

Preferred Qualifications

• Pharmaceutical and/or Medical Device manufacturing experience.
• Professional certifications such as Certified Quality Auditor (CQA), Certified Biomedical Auditor (CBA), Certified Pharmaceutical Professional (CPP), or Regulatory Affairs certifications.

Equal Opportunity Employer

Iatric Manufacturing is an Equal Opportunity Employer and welcomes qualified applicants from diverse backgrounds.

Our Values

We Are Committed To Our RRITE Values

• Renew
• Respect
• Integrity
• Teamwork
• Excellence

Grade 14