PRIMARY PURPOSE
- Lead and develop the Quality team, fostering a culture of accountability, collaboration, and continuous improvement aligned with Volk Values
- Lead, maintain, and continuously improve the QMS in compliance with ISO 13485, FDA Quality System Regulations (21 CFR A7820), 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
- BachelorA9s degree in Engineering (Electrical, Biomedical, Chemical, Industrial, or related field); advanced degree preferred
- 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 A7820), 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
- #volk #LI-MF2
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