Assistant Manager Quality Control (Medical Devices)

Company: Futura Surgicare Pvt. Ltd.
Location: Bengaluru
Experience: 715 Years

Job Description:

Futura Surgicare Pvt. Ltd., a leading manufacturer of medical devices and surgical products, is looking for an experienced Assistant Manager – Quality Control to lead quality control activities and ensure compliance with applicable regulatory and quality standards.

Key Responsibilities:
- Manage incoming, in-process, and finished goods quality control activities.
- Review and approve QC test reports, Certificates of Analysis (COA), and laboratory documentation.
- Ensure compliance with ISO 13485, Good Laboratory Practices (GLP), and Medical Device Regulations.
- Handle deviations, OOS, non-conformances, investigations, CAPA, and root cause analysis.
- Coordinate calibration and maintenance of laboratory equipment.
- Support internal, customer, and regulatory audits.
- Prepare and review SOPs, specifications, and validation documents.
- Monitor quality KPIs and drive continuous improvement initiatives.
- Lead, train,



and mentor the QC team.
- Coordinate with Production, QA, R&D;, Regulatory Affairs, and Supply Chain for quality-related activities.

Candidate Profile
- Bachelor's/Master's degree in Microbiology, Biotechnology, Chemistry, Pharmaceutical Sciences, Biomedical Engineering, or a related discipline.
- 5–8 years of experience in Quality Control within the Medical Device, Pharmaceutical, or Healthcare Manufacturing industry.
- Hands-on experience with ISO 13485, GLP, CAPA, OOS, deviation management, and laboratory operations.
- Solid knowledge of Medical Device Rules (MDR), GDP, calibration, and documentation practices.
- Experience handling audits and leading a team is preferred.
- Strong analytical, communication, and leadership skills.

Preferred Industry
- Medical Devices
- Surgical Products
- Pharmaceuticals
- Healthcare Manufacturing

Key Skills

Quality Control, Medical Devices, ISO 13485, GLP, CAPA, OOS

📌 Assistant Quality Control Manager (Bengaluru)
🏢 Futura Surgicare
📍 Bengaluru