Position Summary:  Responsible for compliance with the requirements of 21CFR Parts 110/111 and 210/211.  This position works closely with the Quality Managers and the Production Department to ensure Quality Assurance compliance with regulatory and customer requirements.  This position works with all supervision and employees to ensure that cGMPs and SOPs, policies and work instructions are being followed.

Essential Functions and Responsibilities:

• Ensures the content and executional effectiveness of the QA Programs.
• Responsible to ensure products meet qualityand 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.
• Maintains Non-TEP book (fills out when Non-TEP product is received).
• Collaborates with the Engineering Administrator and Director of Quality, to ensure compliant validation/qualification of all appropriate equipment and/or processes.
• Responsible for adherence to all Company policies and procedures.
• Works to improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions.
• Supervises a diverse workforce, @ 5-10 Quality Employees.
• Assists Human Resources with interviewing and managing performance.
• Ensures employees are trained according to their roles.
• Addresses complaints and problems, elevates to Leadership when needed.
• Ensures proper PPE’s and Safety procedures are followed.
• Instills a sense of quality through modeled quality behaviors and mindset.
• Flexibly works other shifts, shifts maybe 8, 10 or 12 hours as needed.

Knowledge & Experience:

• 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.