Quality Control Engineer George Philips Medical Engineering

2.0 - 5.0 years

2 - 5 Lacs

Thane

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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 co...

Posted 4 months ago

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Senior Regulatory and Quality Assurance Specialist (Medical Devices ) Janitri Innovations

10 - 15 years

20 - 30 Lacs

Bengaluru, Delhi / NCR

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About Janitri Janitri is a Med-tech company that develops IoT-based smart pregnancy and newborn monitoring devices. Apart from a recent feature in Shark Tank, Janitri has won numerous awards and accolades for its life-saving innovations. About the position: We are seeking a highly motivated and experienced Senior Regulatory and Quality Assurance Specialist to join our team. The successful candidate will be responsible for ensuring compliance with regulatory requirements and maintaining high-quality standards throughout the product lifecycle of Class II medical devices. This role requires a deep understanding of regulatory affairs, quality management systems, and strong attention to detail. R...

Posted 4 months ago

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Regulatory Affairs Manager Nureca .

5.0 - 10.0 years

8 - 10 Lacs

mohali

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Job Title: Regulatory Affairs Manager Key Responsibilities: Prepare and submit applications for CDSCO (Form MD-14/MD-15), USFDA 510(k), BIS registration, and CE Marking. Manage regulatory audits and inspections (USFDA, CE, ISO 13485, BIS). Ensure compliance with 21 CFR 820 (USFDA), EU MDR 2017/745 (CE), Indian MDR 2017 (CDSCO), and BIS standards. Review technical files, labeling, and promotional material for regulatory compliance. Monitor regulatory changes globally and advise internal teams. Support post-market surveillance, reporting, and product registrations. Requirements: Bachelors/Master’s degree in Pharmacy, Life Sciences, Biomedical, or related field. 7–10 years of regulatory affairs...

Posted Date not available

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Compliance Engineer Stanley Black & Decker

4.0 - 7.0 years

9 - 15 Lacs

bengaluru

Hybrid

POSITION TITLE: Engineer -Compliance Documentation LOCATION: Bellandur REPORTING TO: Engineering Manager JOB PURPOSE & CONTEXT: The Industrial Tooling Compliance Specialist is responsible for leading the process of obtaining and maintaining compliance for a variety of end user tools used in automotive and industrial markets. Candidates should be self-motivated individuals with a strong work ethic that have experience with various compliance regulations including (but not limited to) CE, ANSI, ISO, CSA and UL. Additionally, the ideal candidate will have experience with certification processes globally including regional specific marking requirements including PSE, KC, RCM, EQM, UKCA and NOM. ...

Posted Date not available

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Sr Engineer Mechanical Design Engineering - Static Talent Corner Hr Services

5.0 - 8.0 years

5 - 8 Lacs

pune

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ASME/DIN/AD /EN Codes knowledge ISO System implementation updation Design of Equipment’s - Static, pressure vessels heat exchangers Integration of bought out into vessel Detailing engg Cutting layouts, sector layouts

Posted Date not available

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