QA / QC Manager

Job Description

Title: Assistant Manager / Deputy Manager – QA/QC

Department: Quality Arthesys

Minimum Qualification

• Bachelor's or Diploma in Engineering, Biomedical Engineering, Biotechnology, Pharmacy etc.

Minimum Experience

• 8–12 years of QA/QC experience in Medical Device, Pharmaceutical, or Automobile Manufacturing Industry.

1. Key Accountabilities

• Support implementation and maintenance of the Quality Management System (QMS).
• Ensure compliance with ISO 13485, 21 CFR Part 820, applicable MDR requirements, and company procedures.
• Review and approve SOPs, work instructions, protocols, reports, and quality records.
• Manage CAPA, Change Control, Deviations, Non-conformance, Customer Complaints, and Risk Management activities.
• Review Batch Manufacturing Records (BMR) and support batch release activities.
• Coordinate Internal Audits and participate in supplier audits and external regulatory audits.
• Monitor quality KPIs and identify opportunities for continual improvement.
• Conduct root cause analysis and implement effective corrective and preventive actions.
• Coordinate validation documentation review (IQ/OQ/PQ, Process Validation, Cleaning Validation where applicable).
• Support supplier quality management including supplier qualification and performance monitoring.
• Provide QMS and regulatory training to employees.
• Participate in quality culture initiatives and continuous improvement projects.