The Quality Assurance Manager will be responsible for leading the Quality Assurance and Quality Engineering functions. This position ensures that adequate QA/QE and Technician resources are provided for product development and continuing engineering projects and other activities, as necessary. This position directs the development of quality plans and activities to assure achievement of quality goals and objectives.
- Accomplishes quality assurance objectives by training all employees on the Quality procedures and policy
- Achieves quality assurance operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality, and customer-service standards; identifying and resolving problems; completing audits; determining system improvements; implementing change.
- 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; collaborating with other members of management to develop new product and engineering designs, and manufacturing and training methods.
- Prepares quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations.
- Updates job knowledge by studying trends in and developments in quality management; participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations.
- Establishes product quality documentation system by writing and updating quality assurance procedures.
- Maintains product quality by enforcing quality assurance policies and procedures and government requirements
- Contributes to team effort by accomplishing related results as needed
- Lead on any ISO, FDA or other Quality audit
- Work closely with President on new products and 510k submissions
- 3+ years in Quality Assurance leadership within a medical device company, dental highly preferred (Class 3)