Quality Manager - Medical Device/ ISO 13485
$70,000–$95,000 year
On-siteTrevor, Wisconsin, United States
Job Summary
Manage and maintain the ISO 13485 Quality Management System, ensuring compliance with regulatory and customer requirements while overseeing document control and audit preparedness. Lead the Corrective and Preventive Action (CAPA) program, facilitate root cause investigations, and manage nonconforming product processes. Partner with Operations, Engineering, Supply Chain, and Customer Service to drive continuous improvement, support validation activities, and handle customer complaints. Serve as the site's management representative, coordinate internal and external audits, and lead quality personnel development. Successfully maintain ISO 13485 certification and reduce quality issues through effective risk management and supplier oversight.
Required Qualifications
- Bachelor's degree in engineering, Quality, Manufacturing, Life Sciences, or related field
- 5+ years of progressive quality experience in a regulated manufacturing environment
- 3+ years working with ISO 13485 Quality Management Systems
- Experience leading internal, customer, and certification audits
- Strong knowledge of CAPA, nonconformance management, change control, complaint handling, and supplier quality
- demonstrated experience with ISO 13485
- demonstrated experience with CAPA systems
- demonstrated experience with Internal auditing
- demonstrated experience with Risk management
- demonstrated experience with Supplier qualification and supplier corrective actions
- demonstrated experience with Validation activities (IQ/OQ/PQ)
- demonstrated experience with Complaint investigations
- demonstrated experience with Document control and change management
- Reaching, standing, walking, pushing, pulling, lifting, typing, grasping, feeling, talking, hearing, seeing, and repetitive motions
- This position frequently requires the use of hands to handle or feel objects, tools, or controls, and to reach with hands and arms
- The associate must occasionally lift and/or move up to 40 pounds
- Specific vision abilities required by this job include close vision and the ability to adjust focus
Desired Qualifications
- Experience in FDA-regulated manufacturing is highly preferred
- demonstrated experience with Risk management (ISO 14971 preferred)
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