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About the role
Key responsibilities & impact- Responsible for compliance with the requirements of 21CFR 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.
Requirements
What you’ll need- 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.
Benefits
Comp & perks- Health benefits
- Retirement plans
- Paid time off
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
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Hard Skills & Tools
21CFR Parts 11021CFR Parts 11121CFR Parts 21021CFR Parts 211quality assurance planshazard analysescritical control pointsquality documentationquality processesQMS SOPs
Soft Skills
supervisioncollaborationcommunicationproblem-solvingleadershipanalytical skillsorganizational skillsteam managementcustomer complaint investigationtrend analysis