Quality Manager

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.

Qualifications :

Requirements

• Bachelors 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.

Additional Information :

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

Remote Work :

No

Employment Type :

Full-time