Senior QA Manager – FDA-Regulated Manufacturing

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

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.