- Bachelor’s/Diploma in Engineering, Biomedical Engineering, Biotechnology, Pharmacy, or a related field.
Experience
- 8–12 years of QA/QC experience.
- Experience in Medical Device, Pharmaceutical, or Automobile Manufacturing industry.
Key Responsibilities
- Implement and maintain the QMS.
- Ensure compliance with ISO 13485, 21 CFR Part 820, MDR, and company procedures.
- Review and approve SOPs, work instructions, protocols, reports, and quality records.
- Manage CAPA, Change Control, Deviations, Non-Conformances, Customer Complaints, and Risk Management.
- Review BMRs and support batch release.
- Coordinate internal, supplier,
and external audits.
- Monitor quality KPIs and drive continuous improvement.
- Conduct root cause analysis and implement corrective/preventive actions.
- Review IQ/OQ/PQ, Process Validation, and Cleaning Validation documents.
- Manage supplier qualification and performance monitoring.
- Conduct QMS and regulatory training.
- Promote a strong quality culture and continuous improvement.