Company Description
Meril, established in 2006, is a leading global medical device company dedicated to designing, manufacturing, and distributing innovative and high-quality healthcare solutions to improve lives. With a strong focus on research and development, Meril is committed to adhering to international quality standards and scientific excellence. As a part of a diversified multinational organization, Meril operates with a vision to alleviate human suffering and enhance the quality of life. To learn more about the company, visit: Meril's Website.
Role Description
- Prepare and maintain R&D documentation such as design files, protocol reports and records.
- Preparation, review and control of BMR (Batch Manufacturing Record).
- Drafting articles and patents for the assigned projects. (IDF)
- Ensure compliance with approved SOPs and work instructions.
- Perform and support Risk Analysis (as per ISO 14971 principles).
- Monitor and control rejection, rework, and non-conformance.
- Coordinate with QA, QC and Stores for smooth production flow.
- Prepare and update Design History File (DHF) and technical documentation.
- Ensure compliance with QMS, GMP and regulatory requirements.
- Assist during internal and external audits.
Required Skills
- Basic understanding of medical device testing and validation.
- Familiarity with compliance standards and documentation for medical device development is a strong advantage.
- Experience and expertise in Research and Development processes, including design, analysis, and testing of medical devices.
- Rejection & Deviation control
- Good understanding of BMR, GMP, GLP, SOP & QMS practices.
- Ability to work in an on-site capacity and demonstrate strong time management and interpersonal skills.
RequiredQualification
- Bachelor's degree in Engineering / Science (Biomedical / Mechanical / Production).
- 12 years of experience in Production (preferably in Medical Device Industry).
ProficientIn
- MS Office
- Strong knowledge and hands-on experience in R&D processes, manufacturing, and product development workflow
- Analytical skills in conducting experiments, interpreting data, and implementing solution
- Strong knowledge of Manufacturing operations, process optimization, and quality assurance standards
- Analytical and problem-solving skills with attention to detail for ensuring product and regulatory compliance
- Advanced understanding of medical and scientific principles related to healthcare products; prior experience in the medical device industry is a plus.
Vacancy
2 vacancy
available
