Assistant Manager/ Deputy Manager

Degania Medical Devices; Haryana; On-site; INR 614,000 - 2,232,000; Full time

Benefits offered by this job

Cell phone reimbursement

Flexible schedule

Job summary

Degania Medical Device Pvt. Ltd. is seeking an Assistant Manager / Deputy Manager – QA/QC to lead quality systems and regulatory compliance in a hands-on manufacturing environment.

You will implement and monitor QMS processes, coordinate audits, and drive CAPA and risk management to ensure product quality and regulatory adherence. In-person work with a focus on continuous improvement and strong quality culture.

Qualifications

• 8–12 years of QA/QC experience in Medical Device, Pharmaceutical, or related manufacturing.
• Experience implementing and maintaining QMS and regulatory requirements (ISO 13485, MDR, 21 CFR Part 820).
• Review and approve SOPs, work instructions, protocols, reports, and quality records.

Responsibilities

• Implement and maintain the QMS.
• Ensure compliance with ISO 13485, 21 CFR Part 820, MDR, and company procedures.
• Review 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.

Skills

QA/QC

Quality culture

Root cause analysis

CAPA handling

Education

Bachelor’s/Diploma in Engineering or related field

Tools

QMS

ISO 13485

Job description

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