Senior Officer - R&D and Production

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 vacancyavailable