Quality Assurance Manager

Key Responsibilities

Quality Management System (QMS)

• Maintain and continuously improve the sites QMS in compliance with ISO 13485 and FDA QSR requirements.
  
• Oversee document control, change control, training systems, and quality records.
  
• Ensure timely closure of CAPAs, NCs, deviations, and SCARs.
  

Regulatory Compliance

• Ensure compliance with global regulatory requirements for medical devices.
  
• Lead internal audits and support external audits (FDA, notified bodies, customers).
  
• Maintain readiness for inspections and lead audit response activities.
  

Manufacturing Quality Oversight

• Provide quality oversight of production lines, including in-process inspections and finished product release.
  
• Approve process validations, equipment qualifications, and method validations.
  
• Collaborate with Engineering on process improvements and risk mitigation.
  

Supplier Quality

• Manage supplier qualification, audits, incoming inspection, and supplier performance metrics.
  
• Lead investigation and resolution of supplier-related quality issues.
  

Risk Management

• Lead risk management activities in accordance with ISO 14971.
  
• Ensure risk assessments are current, comprehensive, and integrated with design and manufacturing processes.
  

Team Leadership

• Supervise and develop QA staff, including Quality Engineers, QC Technicians, and inspectors.
  
• Provide training on quality and regulatory requirements across the organization.
  
• Promote a strong quality culture and continuous improvement mindset.
  

Quality Metrics & Reporting

• Track and report key quality indicators (CAPA trends, scrap rates, complaints, audit findings, etc.).
  
• Present quality performance data to senior leadership and support strategic planning.
  

Customer Quality

• Investigate customer complaints, coordinate root-cause analysis, and implement corrective actions.
  
• Communicate quality information and resolution status to customers as needed.
  

Qualifications

Required:

• Bachelor’s degree in Engineering, Life Sciences, or related field.
  
• 5+ years QA experience in a medical device or regulated manufacturing environment.
  
• In-depth knowledge of

  FDA QSR (21 CFR 820), ISO 13485, and ISO 14971

  .
• Experience managing audits and leading a QMS.
  
• Strong understanding of CAPA, root-cause analysis, and risk management tools (FMEA, 5 Whys, Fishbone, etc.).
  
• Leadership experience managing QA or QC teams.
  

Preferred:

• Master’s degree or advanced training in quality or regulatory fields.
  
• Six Sigma Green/Black Belt certification.
  
• Experience with EU MDR, MDSAP, and validation protocols.
  
• Strong proficiency in statistical analysis & quality tools (SPC, Minitab, etc.).