Quality Manager
On-siteMentor, Ohio, United States
Job Summary
Lead and develop the Quality team while maintaining and improving the QMS in compliance with ISO 13485, FDA regulations, and global standards. Serve as the Management Representative for internal and external audits, including ISO and FDA inspections. Analyze quality data to identify improvement opportunities, develop metrics, and ensure effective document control, change management, and CAPA processes. Identify and implement domestic and international regulatory requirements, acting as a liaison with regulatory teams. Lead quality engineering activities such as design controls, risk management, and verification/validation support. Ensure Design History Files, Device Master Records, and Device History Records are complete and compliant. Support New Product Introduction and supplier quality management, including assessments and corrective actions. Requires a Bachelor's degree, 5+ years in Quality Engineering, and experience in a regulated manufacturing environment.
Required Qualifications
- Bachelor's degree
- 5+ years of experience in Quality Engineering, Control and/or Assurance
- 1+ years of experience in Leadership or Management
- Must come from a regulated manufacturing environment
- Experience with CAPA, nonconformance investigations, and root cause analysis methodologies
- Knowledge of design controls, risk management (FMEA), verification, and validation processes
- Experience supporting audits and regulatory inspections
Desired Qualifications
- Engineering / Technical undergrad and/or advanced degree
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