Job Summary We are looking for a detail-oriented and experienced Quality Control Engineer to join our manufacturing team. The ideal candidate will be responsible for implementing and overseeing quality control processes, ensuring all products meet national and international medical device standards, and working closely with production and R&D to resolve quality issues. Key Responsibilities Conduct in-process and final quality inspections for medical devices in accordance with GMP and ISO 13485 standards. Develop and maintain QC protocols, SOPs, and inspection reports. Ensure compliance with regulatory requirements such as CDSCO, MDR 2017, ISO 13485, and CE. Perform root cause analysis and corrective/preventive action (CAPA) for quality issues and non-conformities. Liaise with production, QA, and R&D teams to address quality-related challenges. Monitor and analyze data from incoming raw materials, in-process controls, and finished goods. Maintain proper documentation and assist in internal/external audits. Qualifications & Skills Bachelor's degree in Engineering (preferably in Biomedical, Mechanical, or Industrial Engineering). 25 years of experience in a QC role within the medical device or pharmaceutical industry. Strong knowledge of ISO 13485, QMS, GMP, and applicable regulatory standards. Hands-on experience with measurement tools (e.g., Vernier calipers, micrometers, leak testers). Proficiency in documentation and data analysis. Familiarity with cleanroom protocols and sterilization validation is a plus.
Job Summary We are looking for a skilled and precision-focused Die Maker to join our in-house tooling and production team. The ideal candidate will be responsible for fabricating, assembling, maintaining, and repairing dies, molds, and precision tools used in the production of plastic medical disposables. The role requires hands-on expertise in working with toolroom machinery and interpreting technical drawings to ensure accurate and high-quality output. Key Responsibilities Manufacture, assemble, and maintain high-precision injection molds, extrusion dies, and other tools used for plastic mould manufacturing. Read and interpret technical drawings, CAD designs, and tooling blueprints. Operate toolroom machines such as milling machines, surface grinders, lathes, and EDMs. Perform preventive maintenance and repairs on dies to reduce production downtime. Collaborate with design and production teams to improve tool designs and troubleshoot manufacturing issues. Ensure tools are manufactured and maintained within tight tolerances and in accordance with GMP standards. Maintain proper documentation of tool usage, maintenance logs, and change records. Qualifications & Skills ITI / Diploma in Tool & Die Making or Mechanical Engineering. 2-7 years of experience as a die/tool maker in the plastic injection molding or medical device industry. Strong knowledge of toolroom machinery, die-fitting, and die-polishing. Ability to read and understand detailed engineering drawings. Experience with injection mold making for medical-grade plastic parts is an added advantage. Attention to detail, high precision, and strong problem-solving abilities.
Job Summary We are seeking a proactive and detail-oriented Electronics Engineer to join our engineering and product development team. The ideal candidate will be responsible for the development, testing, and troubleshooting of electronic components used in our range of medical devices. This includes working on embedded systems, PCBs, sensors, and ensuring compliance with relevant medical safety standards. Key Responsibilities Design, develop, and test electronic circuits and systems used in medical devices and sensor-based components. Work on PCB design, assembly, and troubleshooting for new and existing products. Collaborate with R&D and production teams to improve product functionality and resolve design issues. Support in the development of embedded systems and microcontroller-based applications. Perform root cause analysis and corrective actions for electronic failures during production or quality inspection. Ensure products meet applicable standards such as IEC 60601 and regulatory requirements including CE and CDSCO guidelines. Maintain accurate documentation for design history, test results, and change control. Assist in calibration, validation, and periodic maintenance of electronic test equipment. Qualifications & Skills Bachelor's degree in Electronics, Instrumentation, or Electrical Engineering. 25 years of experience in electronics design or maintenance. Understanding of analog/digital circuitry, signal conditioning, and sensor interfacing. Familiarity with compliance standards such as ISO 13485, IEC 60601, and EMI/EMC requirements is a plus. Strong analytical, troubleshooting, and documentation skills.
Role & responsibilities Work on day to day production of medical devices in a clean, controlled environment Understand product specifications, drawings and quality requirements Monitor process parameters, yields and rejections and support continuous improvement Carry out in process and final inspection as per approved procedures Use basic measuring instruments for inspection and documentation Prepare and maintain batch records, inspection reports and other production/QA documentation Ensure that all activities comply with ISO 13485, ISO 14971, EU MDR and internal SOPs Co ordinate with Production, QA, Maintenance, Stores and Sterilization teams for smooth operations Assist senior engineers during internal and external audits by providing records and technical clarifications Preferred candidate profile M E / M Tech in Biomedical Engineering or Biotechnology B E / B Tech in allied disciplines such as Electronics / Instrumentation / Mechanical may be considered only if the candidate has prior experience in medical device manufacturing, QA or testing Technical skills Basic understanding of medical device lifecycle and risk management concepts Exposure to quality systems such as ISO 13485, ISO 14971, EU MDR is desirable Ability to read basic engineering drawings and follow work instructions and SOPs Good documentation habits and comfort with Excel/Word for recording data and preparing reports Soft skills and other requirements Strong sense of responsibility, attention to detail and discipline in following procedures Willingness to work in a regulated manufacturing environment rather than a purely hospital role Good communication skills to interact with production operators, supervisors and management Candidates residing in or willing to relocate to Ambernath, Badlapur, Kalyan, Dombivli or nearby areas Preference for candidates looking for a stable, long term role in medical device manufacturing