Assistant Manager/ Deputy Manager

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Assistant Manager / Deputy Manager – QA/QC

Company: Degania Medical Device Pvt. Ltd.

Department: Quality

Qualification

- 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.

Pay: ₹55,000.00 - ₹200,000.00 per month

Benefits:

• Cell phone reimbursement
• Flexible schedule

Work Location: In person