Deputy QC Manager

Madhu Instruments; New Delhi; On-site; INR 1,200,000 - 2,100,000; Full time

Job summary

Madhu Instruments seeks a seasoned Quality Control leader to drive GMP/ISO compliance in a medical devices manufacturing setting. You will oversee documentation, stability testing, and validation activities, while guiding a QC team to ensure product quality from raw materials to finished goods.

Responsibilities include deviation handling, CAPA support, and collaboration with cross-functional teams to ensure data integrity and passing audits.

Qualifications

• 7-10 years of work experience in Quality Control in medical devices manufacturing unit.
• Excellent computer skills, including MS Office.
• Strong communication skills, including the ability to explain and teach methodologies.
• Understanding of medical device manufacturing methods and procedures.

Responsibilities

• Lead Quality Control operations and ensure GMP, ISO, regulatory, and QMS compliance.
• Manage BPRs, specifications, test methods, sampling plans, SOPs, and quality documentation.
• Oversee raw material, packaging, in-process, and finished product testing, including chemical analysis.
• Plan and manage stability studies, equipment validation including IQ, OQ, PQ and laboratory activities.
• Handle deviations, non-conformances, product disposition, quality risks, and CAPA support.
• Lead, train, and develop the QC team and provide cross-functional technical support.
• Support CE, FDA, ISO, customer, and regulatory audits/inspections.
• Ensure laboratory quality systems, data integrity, and documentation compliance.

Skills

Quality control experience

MS Office

Strong communication

Medical device manufacturing

Team player

Organizational skills

Education

B.Sc./B.Tech/B.Pharma degree

Job description

Role & responsibilities

• Lead Quality Control operations and ensure GMP, ISO, regulatory, and QMS compliance.
• Manage BPRs, specifications, test methods, sampling plans, SOPs, and quality documentation.
• Oversee raw material, packaging, in-process, and finished product testing, including chemical analysis.
• Plan and manage stability studies, equipment validation including IQ, OQ, PQ and laboratory activities.
• Handle deviations, non-conformances, product disposition, quality risks, and CAPA support.
• Lead, train, and develop the QC team and provide cross-functional technical support.
• Support CE, FDA, ISO, customer, and regulatory audits/inspections.
• Ensure laboratory quality systems, data integrity, and documentation compliance.
• Sterilization & Microbiology Expertise
• EO, Gamma & Steam Sterilization Validation ISO 11135, ISO 11137 & ISO 17665.
• Cleanroom Qualification & Environmental Monitoring ISO 14644.
• Bio burden & Sterility Testing ISO 11737.
• BET/LAL & EO Residual – USP & ISO 10993-7:2026

Preferred candidate profile

• 7-10 years of work experience in Quality Control in medical devices manufacturing unit.
• Excellent computer skills, including MS Office
• Strong communication skills, including the ability to explain and teach methodologies
• Understanding of medical device manufacturing methods and procedures
• Approved chemist (analytical or manufacturing)
• A confident and determined approach
• Excellent organizational & time management skills
• Team player

Qualification

B.Sc./B.tech/B.Pharma degree only, masters may be preferred.