Quality Manager
On-siteMentor, Ohio, United States
Mentor, Ohio, United StatesOn-siteFull TimeBachelors DegreeLarge
Full TimeBachelors DegreeLarge
Job Summary
Lead and develop the Quality team while fostering a culture of accountability and continuous improvement aligned with Volk Values. Maintain and continuously improve the Quality Management System (QMS) in compliance with ISO 13485, FDA Quality System Regulations (21 CFR §820), and applicable global regulations. Serve as Management Representative for ISO and certification audits, leading all internal and external audits, including ISO, FDA, and customer audits. Analyze quality data and trends to identify improvement opportunities; develop and report quality metrics to leadership to ensure visibility and accountability.
Required Qualifications
- Bachelor's degree in Engineering (Electrical, Biomedical, Chemical, Industrial, or related field)
- 5+ years of experience in quality engineering or quality management within a regulated manufacturing environment
- Strong knowledge of ISO 13485, FDA Quality System Regulations (21 CFR §820), and medical device compliance requirements
- 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
- Strong analytical, problem-solving, and data-driven decision-making skills
- Ability to work cross-functionally and influence outcomes at multiple levels of the organization
Desired Qualifications
- advanced degree
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