
Medical Device Quality Manager
2 days ago
Description:
- A strong background in medical devices and quality management is required for this role.
Responsibilities:
- We are seeking a skilled professional to develop and implement quality management systems.
- The ideal candidate will have experience in assessing and auditing medical devices to ensure compliance with regulatory requirements.
- Collaboration with cross-functional teams is essential to drive innovation and improvement in our organization.
Requirements:
- A minimum of 10 years of experience in relevant field of healthcare products or related activities is necessary.
- 5+ years of experience in quality management is mandatory.
- Proficiency in ISO 13485, MDD 93/42/EEC, Indian Medical Device Regulations, MDR 2017/745, MDSAP, and IMDR is required.
- Experience with Risk Management EN ISO 14971 is an advantage.
- Solid knowledge of non-active devices and sterilization processes is essential.
Candidates should be proactive team players with excellent communication skills.
A Bachelor's degree in Engineering or a related field is required.
We offer a dynamic work environment and opportunities for career growth and development.
Our company values creativity, innovation, and teamwork.
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