Job Details
Quality Manager
Research Group · Mentor, OH
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Responsibilities
- Lead and develop the Quality team, fostering a culture of accountability, collaboration, and continuous improvement aligned with values.
- Lead, maintain, and continuously improve the 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.
- Ensure effective document control, change management, and CAPA processes.
- Identify, implement, and ensure compliance with domestic and international regulatory requirements.
- Act as a liaison with regulatory teams to ensure alignment of quality programs and standards.
- Lead quality engineering activities, including design controls, risk management, and verification/validation support.
- Provide expertise in statistical sampling, analysis, and process controls to improve product quality.
- Ensure Design History Files (DHFs), Device Master Records (DMRs), and Device History Records (DHRs) are complete and compliant.
- Support New Product Introduction (NPI) to ensure quality is embedded from concept through commercialization.
- Support supplier quality management, including assessments, monitoring, and corrective actions.
Requirements
- Bachelor’s degree required; Engineering / Technical undergrad and/or advanced degree preferred.
- 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.