Company Description Madhu Instruments Pvt Ltd, based in New Delhi, India, is a respected supplier of high-quality ophthalmic products serving both domestic and international markets. The company offers a diverse product range, including specialty instruments for cataract and phaco surgery, keratoplasty, vitreo-retina procedures, diagnostic strips, surgical and diagnostic lenses, and fluid management devices. It also provides teaching and training devices to support ophthalmic education and practice. Madhu Instruments focuses on innovation and continuous improvement of existing products to meet and exceed customer expectations. The organization is committed to supporting the ophthalmic community with reliable, performance-driven solutions.

Role Description:

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

Qualifications
7-10 years of work experience in Quality Control in medical devices manufacturing unit.
Excellent computer skills, including MS Office
Robust communication skills, including the ability to explain and teach methodologies
Understandin

📌 Quality Control Manager (India)
🏢 Madhu Instruments
📍 India