Head of Quality Control

Role Overview: As the QC Head, you will be responsible for leading the Quality Control function in medical device manufacturing to ensure that products meet global regulatory, safety, and performance standards. Your role will involve overseeing raw material testing, in-process quality checks, stability studies, validation protocols, and final product release in compliance with applicable regulatory guidelines. Key Responsibilities: - Establish, implement, and maintain QC protocols, SOPs, testing procedures, and specifications. - Ensure batch-wise testing, documentation, and release of raw materials, intermediates, and finished products. - Oversee microbiological and biochemical testing for sterile and non-sterile medical devices. - Conduct periodic trending of QC results and take corrective actions. - Ensure compliance with ISO 13485:2016, ISO 14971 (Risk Management), EU CE, and CDSCO norms. - Prepare documentation for audits, regulatory submissions, CAPA, NCR investigations, SCAR, change control, and traceability. - Manage QC laboratory infrastructure, calibration, and validation of analytical instruments. - Lead sterility assurance, endotoxin testing, and environmental monitoring in cleanroom and production areas. - Design and monitor stability studies for product shelf-life determination. - Train and guide QC managers, executives, analysts, and technicians. - Coordinate with R&D, QA, Production, Validation, and Regulatory Affairs. - Implement quality improvement initiatives using Lean / Six Sigma methodologies. - Support and lead investigations for deviations, OOS (Out-of-Specification) results, and customer complaints. Qualification Required: - Strong knowledge in microbiology, biocompatibility, plasma/chemical additives, or IVD reagent chemistry. - Hands-on experience with laboratory QC instrumentation (HPLC, UV-Vis, autoclave validation, endotoxin analyzers, etc.). - Sound understanding of sterile manufacturing, cleanroom classifications, and aseptic techniques. - Ability to interpret regulatory and audit requirements. - Strong leadership, communication, and documentation skills. Additional Details: No additional details of the company are mentioned in the job description.,