Senior Quality EngineerQuality Assurance Engineer
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Job Location:
Eden Prairie, MN - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
My client is a global CDMO in regenerative medicine offering a differentiated portfolio of allograft and xenograft biomaterials at scale. As their Senior Quality Engineer you will lead quality assurance initiatives across a manufacturing facility and supervise the QA Engineering team. The work spans validation risk management continuous improvement and cross-functional product development at a company with real depth and global reach.
Why you should apply
- Lead and grow a QA Engineering team with real influence over hiring performance and how the function develops
- Cross-functional role with visibility into product launches regulatory submissions and manufacturing improvement across a fast-growing regenerative medicine CDMO
- Preferred certifications (ASQ CQE/CQA/CBA Lead Auditor AATB/CTBS) are recognized and valued
What youll be doing
- Serve as a lead member of cross-functional teams coordinating deliverables for manufacturing process improvement
- Supervise the QA Engineering team including performance management corrective action and hiring
- Review quality KPI data and drive continuous improvement across operations value streams
- Review validations and risk management activities supporting regulatory submissions and product launches
- Lead nonconformance investigations change management workflows and continuous improvement initiatives
About you
- Be able to do the job as described.
- Hands-on experience with test method validation including sampling plan development and validation layout across multiple TMV types
- Background with Class II and/or Class III medical devices
- Experience supporting design to manufacturing transfers
- Track record of coaching or mentoring junior quality engineers
Required Experience:
Senior IC
About Company
Niche executive search firm with 30+ years specializing in executive search and staffing in Medical Device, Biotech, Pharma, and Diagnostics. Jacobs Management Group is a WBENC certified retained and contingent search firm with 30+ years of industry success and a national network.
