5+ years of experience in Quality Engineering, Control, and/or Assurance.
1+ years of leadership or management experience.
Experience in a regulated manufacturing environment.
Familiar with CAPA, nonconformance investigations, and root cause analysis.
Knowledge of design controls, risk management (FMEA), and validation processes.
Proven track record supporting audits and regulatory inspections.
Responsibilities
Lead and develop a culture of accountability in the Quality team.
Maintain and improve the Quality Management System (QMS) adhering to ISO 13485 and FDA regulations.
Serve as Management Representative during ISO and certification audits.
Analyze quality data to identify improvement opportunities and report metrics to leadership.
Manage document control, change management, and CAPA processes.
Implement and ensure compliance with regulatory requirements effectively.
Act as a liaison to regulatory teams to align quality programs.
Benefits
Comprehensive health and wellness benefits.
Opportunities for continuous professional development and training.
Collaborative and innovative work environment.
Flexible work arrangements to support work-life balance.
Full Job Description
Job Description
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.
