Quality Manager

Responsibilities

• Responsible for compliance with the requirements of 21
  
  CFR Parts 110/111 and 210/211.
• Works closely with the Quality Managers and the Production Department to ensure Quality Assurance compliance with regulatory and customer requirements.
• Ensures the content and executional effectiveness of the QA Programs.
• Responsible to ensure products meet quality and efficiency standards set by the company.
• Develops quality assurance plans by conducting hazard analyses; identifying critical control points and preventive measures; establishing critical limits, monitoring procedures, corrective actions, and verification procedures; monitoring inventories.
• Validates quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification; writing and updating quality assurance procedures.
• Maintains and improves product quality by completing product, company, system, compliance, and surveillance audits; investigating customer complaints.
• Prepares quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re‑validations.
• Direct and supervise Quality Assurance Team.
• Reviews and updates QMS SOPs, WIs, and Forms, as required, to match current practices.
• Maintains Major Equipment and Portable Equipment Log books.
• Collaborates with the Engineering Administrator and Director of Quality, to ensure compliant validation/qualification of all appropriate equipment and/or processes.

• Bachelor’s degree, required or equivalent combination.
• 3‑5 years Quality experience required.
• Supervision experience required.
• Experience in managing various levels of employees with different educational backgrounds, work style habits, and employment histories.