Position Summary: We are seeking an experienced and proactive Quality Control Manager with a strong background in In Vitro Diagnostics (IVD) to lead and oversee all QC activities within our manufacturing and development operations. The QC Manager will be responsible for ensuring that IVD products meet internal quality standards and comply with international regulatory requirements. This role plays a key part in managing a QC team, improving processes, and supporting product development and commercial release. Role & responsibilities Lead and manage the Quality Control team, ensuring daily testing activities are conducted efficiently and in compliance with regulatory requirements (ISO 13485, FDA 21 CFR Part 820, and CE-IVD). Develop, implement, and maintain QC procedures for raw materials, in-process controls, and final product testing for IVD devices, including immunoassays, molecular diagnostics, and rapid tests. Oversee method validation, equipment qualification (IQ/OQ/PQ), and routine calibration and maintenance of laboratory instruments. Review and approve QC test results, reports, and batch records, ensuring timely product release. Manage investigations of non-conformances, deviations, out-of-specification (OOS) results, and implement corrective and preventive actions (CAPAs). Participate in cross-functional teams for new product development, transfer-to-manufacturing activities, and continuous improvement initiatives. Ensure compliance with GLP/GMP requirements and prepare for internal and external audits (e.g., ISO, FDA, notified bodies). Provide leadership, training, and mentorship to QC staff, fostering a culture of quality and accountability. Monitor QC metrics and KPIs, and report regularly to senior management. Maintain and improve the Quality Control Laboratory environment, including documentation, data integrity, and safety practices. Education: Bachelors or Masters degree in Biotechnology, Biochemistry, Microbiology, Life Sciences, or a related field. Experience: Minimum 610 years of experience in Quality Control, with at least 3 years in a managerial or supervisory role within the IVD or medical device industry. Skills: In-depth knowledge of IVD regulations and quality standards (ISO 13485, FDA QSR, CE-IVD). Strong leadership, team-building, and project management skills. Proven experience in implementing and improving QC systems and processes. Excellent problem-solving skills and experience with RCA and CAPA tools. Proficiency in LIMS, statistical analysis, and data management tools. Preferred candidate profile Experience with regulatory submissions, audits, and inspections (FDA, ISO, EU MDR). Familiarity with risk management (ISO 14971), design controls, and product lifecycle management. Quality certifications (e.g., ASQ CQM/OE, Six Sigma Green/Black Belt) are a plus
Responsibilities: Packing / Assembly Line / Loading-Unloading Support production and maintain discipline at work Follow safety and quality standards Minimum Qualification: 10th 12th Pass ITI Diploma Male candidates preferred Over time allowance Employee state insurance Provident fund Office cab/shuttle
Key Tasks: QC checks (raw materials, in-process, final product) assist with documentation Support equipment calibration & SOP adherence Collaborate with production and QC teams for corrective actions Ability to run laboratory instruments.
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