Quality Assurance Manager
Quality Assurance Manager needed in the Wallingford, CT area in the medical devices industry. This is a great opportunity for someone to be well compensated and work among passionate and dedicated individuals.
Our client is a growing medical device firm that offers amazing work-life balance and a corporate culture that rewards individual accomplishments and team success.
- Coordination and complete calibration of test equipment and gages.
- Maintain calibration records and work with calibration vendors.
- Assist with determining gage requirements.
- Lead and coordinate internal process validations (IQ, OQ, PQ), and where appropriate, supplier validations including writing protocols, data analysis, statistical rationales, and reports.
- Assist with design validations where needed.
- Work with Manufacturing on preventive maintenance activities (including writing of Preventive Maintenance procedures as needed).
- Work with Manufacturing and Quality Control to develop test methods (including packaging integrity testing and barcode testing).
- Lead cross-functional teams in project management when necessary.
- Coordinate validation activities and planning associated with Unique Device Identification (UDI).
- Development of sampling plans, statistical methodology, and statistical techniques.
- Coordinate ship testing.
- Lead or assist in corrective and preventive action investigation and problem-solving.
- Lead trend analysis, data entry, and development of methods for trending.
- Support the setup shelf life studies.
- Support with performing various product and packaging tests.
- Determine gaging requirements.
- Lead internal audits and supplier audits.
- Assist with preparation and filing of regulatory and quality documentation.
- Assist with Device History Record (DHR) review and product release process to ensure that DHRs are complete and that released products meet specifications and requirements.
- Assist with customer complaints investigations and documentation as needed.
- Assist with document control including ensuring revised or new procedures have been reviewed and approved by required personnel and that procedures are accessible to employees in required locations and obsolete versions are appropriately archived.
- Complete assigned corrective and preventive actions (CAPAs) ensuring that CAPA forms are complete, corrective and preventive actions have been implemented and effectiveness has been verified.
- Assist with and/or coordinate employee training as needed.
- Work with Manufacturing on a regular basis to ensure products are meeting specifications, defects and nonconformities are being handled appropriately, and compliance with regulatory requirements is being maintained.
B.S. degree in a technical discipline, or the equivalence in professional experience and accomplishments.
- Familiar with quality system regulations: cGMP, 21 CFR 820, QSR, ISO 13485, CMDR and the MDD.
- Minimum of 10 years of experience in the medical device industry, with experience in quality and manufacturing.
- Experience with FDA establishment inspections.
- Proficient with Word and Excel.
- Experience with Minitab software preferred.
- ASQ Certified Quality Manager (CQM) or Certified Quality Aud.
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