Quality Manager - Medical Device
Opportunity to lead the Quality Department for a Medical Device Business
Strategically Develop Quality Department reporting to VP of Regulatory Affairs
About Our Client
Our client is a global leader in minimally invasive surgery. They are apart of an extraordinary workforce that builds, sells, and repairs well-crafted medical products that change lives every day.
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
- Oversee Quality Assurance Team with responsibilities include planning, assigning, and directing work; performance evaluation; disciplining employees; addressing complaints and resolving problems.
- Compliance with all applicable regulatory requirements for medical devices such as FDA Quality System Regulation, 21 CFR 820, GMP guidelines, GDP, ISO 13485, ISO 14971 and other regulatory requirements.
- Manages multiple, often concurrent, projects and meets deadlines.
- Primary owner of CAPA system - ensure procedures are established, processes are maintained and overall effectiveness of the quality system is achieved.
- Manage investigations of quality system issues by compiling data and applying statistical methods that determine impact and urgency of adverse trends or events.
- Prepare Quality budget for QA/QC and responsible for SAP verification and maintenance of budget files.
- Establish site master equipment validation plan with inventory of processes and re-validation criteria. Develop and execute equipment validations as needed or assigned. Participate in OQ/PQ projects.
The Successful Applicant
- B.S. Degree in applicable field: biology, electro-mechanical, bio-medical or chemical engineering
- At least 6 Years in a Medical Device Manufacturing Facility
- 4 Years minimum of Quality Management Experience in a Medical Device Facility
- 8-10 Years Minimum of experience working within a Quality Department
- Demonstrated Experience leading CAPA System
- Certifications demonstrating applied understanding of medical device quality system requirements, such as AAMI Quality System or sterilization certificates, Certified ASQ or ISO Lead Auditor and Regulatory Affairs Professional Society (RAPS).
- Lead Auditing experience is Required
- Have Direct supervision of Quality Assurance Team
- Planning, assigning, and directing work; performance evaluation; disciplining employees; addressing complaints and resolving problems
What's on Offer
- Competitive Base Salary between $90-$100K
- 401K Matching
- Summer Hours (Fridays off)
- Opportunity to Advance Career
- Comprehensive health benefits (Medical, Dental, Vision)
- Tuition Reimbursement