Opportunity Description
The Quality Assurance Manager who will own responsibility for implementing and managing the QMS system and all quality areas for the Company, a medical device distributor and field service provider. Initial focus of the QMS system will be on our imported consumables, followed by our rebuilt equipment and field service.
Job Duties
- Develop, implement, manage and document a quality management system in conjunction with FDA requirements under CFR 21 Part 820
- Establish and execute internal quality audit processes
- Develop, document and institute recall procedures
- Create SOP’s for the retention of quality records, device history records and overall record retention
- Handle both customer and supplier complaints and reporting, including CAPA and SCAR documentation
- Participate in product development processes, conduct quality reviews
- Review and maintain supplier and manufacturer quality, including new vendor approvals
- Develop and maintain key vendor quality KPI’s and scorecards
- Coordinate all aspects of the regulatory process and approvals
- Monitor corporate-wide compliance with quality standards
- Train staff on SOP compliance as required
- Ensure labeling and packaging requirements are met and consistent
- Serve as lead contact for all communications with FDA
- Prepare for and lead customer quality assurance audits
- Prepare and send customer communications as needed e.g. quality control letters
- Complete and respond to customer survey requests
- Develop and report on Quality KPI’s
- Serve as the “Quality Champion” to promote a culture of quality at all points in the Value Stream
- Review performance breakdowns in all departments, coordinate improvement efforts
- field service recall visits, shipping errors, order processing errors, product non-conformances, equipment warranty failures, any other customer complaints
Experience & Skills Required
- A minimum of 8-10 years’ experience in the quality arena, medical device experience strongly preferred
- Experience with Quality Control in distribution environments
- Experience working closely with new product development teams
- Experience in developing policy and procedure and carrying through to implementation
- Expansive knowledge, experience and understanding of FDA requirements under CFR 21 Part 820 and/or ISO 13485:2016
- Experience and knowledge of products subject to FDA 510(K) regulations a plus
- Strong communication skills and superior attention to detail
- Creative thinker who can maintain quality control while also considering the needs of the business