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.