Quality Manager

Research Group • Mentor, OH

7d

About The Position

The Quality Manager will lead and develop the Quality team, fostering a culture of accountability, collaboration, and continuous improvement. This role is responsible for leading, maintaining, and continuously improving the Quality Management System (QMS) in compliance with ISO 13485, FDA Quality System Regulations (21 CFR 820), and applicable global regulations. The Quality Manager will serve as the Management Representative for ISO and certification audits, leading all internal and external audits, including ISO, FDA, and customer audits. This position requires analyzing quality data and trends to identify improvement opportunities and reporting quality metrics to leadership. The role ensures effective document control, change management, and CAPA processes, and identifies, implements, and ensures compliance with domestic and international regulatory requirements. The Quality Manager will act as a liaison with regulatory teams, provide expertise in statistical sampling, analysis, and process controls, and ensure Design History Files (DHFs), Device Master Records (DMRs), and Device History Records (DHRs) are complete and compliant. Support for New Product Introduction (NPI) and supplier quality management is also a key aspect of this role.

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.

Nice To Haves

• Engineering / Technical undergrad and/or advanced degree preferred.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager