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16 hours ago
We are seeking a seasoned medical device engineer to fill this key role.
Job Description:- The ideal candidate will have extensive experience in quality management, regulatory affairs, and research and development within the medical devices industry.
- They will be responsible for conducting thorough assessments and audits of medical devices to ensure compliance with ISO 13485, MDD 93/42/EEC, Indian Medical Device Regulations, and MDR 2017/745.
- A strong background in risk management, non-active devices, and sterilization processes is essential.
- Excellent communication and teamwork skills are required as the role involves working closely with cross-functional teams.
The successful candidate will possess a minimum of 10 years of professional experience in relevant fields, with at least 5 years of experience in quality management.
Key Responsibilities:- Conduct comprehensive assessments and audits of medical devices to guarantee adherence to relevant regulations.
- Develop and implement effective quality management systems to ensure high standards of product safety and performance.
- Collaborate with cross-functional teams to drive innovation and improvement initiatives.
- Remain up-to-date with industry developments and advancements in medical device technology.
This is an exceptional opportunity for a highly skilled and experienced Senior Device Engineer to make a valuable contribution to the organization.
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