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.

All your information will be kept confidential according to EEO guidelines.