QA Manager II

Ultipro; Morristown (TN); On-site; USD 120,000 - 170,000; Full time

Job summary

Iatric Manufacturing in Morristown, TN is seeking a strategic Quality Assurance Manager II to lead our Quality Assurance, Quality Control, and Quality Engineering teams in an FDA-regulated 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

Qualifications

• Bachelor's degree in Science, Engineering, or related technical discipline.
• 10+ years of Quality Assurance leadership in an FDA-regulated setting.
• Experience leading QA, QC, and QE functions.
• Strong knowledge of FDA regs, cGMP, ISO 13485, CAPA, RCA, and risk management.
• Experience with process, cleaning, software, and analytical method validation.
• Exposure to Statistical Process Control and Lean Manufacturing.

Responsibilities

• Lead QA, QC, and QE activities.
• Oversee investigations, deviations, nonconforming materials, CAPA, and QA systems.
• 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 regulatory inspections.
• Collaborate with customers, suppliers, and cross-functional teams.
• Support new product introductions and process validation activities.
• Develop, mentor, and coach quality professionals.
• Lead site quality reviews and management review activities.

Skills

FDA regulations

cGMP

ISO 13485

CAPA

Root Cause Analysis

Risk Management

Process Validation

Software Validation

Analytical Validation

Statistical Process Control

Lean Manufacturing

Quality Leadership

Quality Assurance

Education

Bachelor's degree in Science or Engineering

Job description

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

We are committed to our RRITE Values:

• Renew
• Respect
• Integrity
• Teamwork

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.