QA Manager II

Rockline Industries; Morristown (TN); On-site; USD 120,000 - 165,000; Full time

Job summary

Iatric Manufacturing in Morristown, TN seeks a Quality Assurance Manager II to lead QA, QC, and QA Engineering in a regulated manufacturing setting. You will drive quality initiatives, partner with Operations, Engineering, and Global Quality, and support business growth.

The role emphasizes regulatory compliance, product safety, and developing high-performing teams with a focus on audits, CAPA, and risk management.

Qualifications

• Bachelor's degree in Science, Engineering, or related technical field.
• 10+ years of QA leadership experience in an FDA-regulated manufacturing environment.
• Experience leading QA, QC, and QA Engineering functions.
• Strong knowledge of FDA regs (21 CFR Parts 11, 210, 211, 820), cGMP, ISO 13485, CAPA, RCA, and risk management.

Responsibilities

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

Skills

QA Leadership

FDA Regulations

Team Leadership

CAPA & RCA

Lean Manufacturing

SPC

Process Validation

Education

Bachelor's degree in Science/Engineering

Tools

QMS (Quality Management System)

Statistical software (SPC)

Job description

Quality Assurance Manager II

Iatric Manufacturing | Morristown, TN

Full-Time | Exempt | On-Site

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.

Why Join Iatric?

At Iatric, you'll have the opportunity to influence site strategy, build high-performing teams, and help manufacture products that meet the highest standards of quality and safety. We offer a collaborative environment where continuous improvement, innovation, and professional growth are valued.

Our Values

• Renew
• Respect
• Integrity
• Teamwork
• Excellence

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

Grade 14

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.