Medical Device Quality Specialist
22 hours ago
Senior Medical Device Engineer Position
At the forefront of medical device innovation, we seek a seasoned Senior Medical Device Engineer to drive our product's quality and compliance with regulatory standards.
The Role:
Our ideal candidate will possess extensive experience in auditing and assessing medical devices to ensure adherence to ISO 13485, MDD 93/42/EEC, and Indian Medical Device Regulations.
- Lead audits and assessments of medical devices to guarantee regulatory compliance.
- Maintain an in-depth knowledge of medical device regulations including MDR 2017/745, MDSAP, and IMDR.
- Collaborate closely with cross-functional teams to guarantee timely project completion.
Requirements:
We're looking for candidates who embody expertise in the following areas:
- 10+ years of professional experience in healthcare products or related industries.
- Minimum 5 years' experience in quality management with a focus on medical devices.
- In-depth knowledge of ISO 13485, MDD 93/42/EEC, and Indian Medical Device Regulations.
- Experience with risk management EN ISO 14971.
- Strong understanding of non-active devices and sterilization processes.
Preferred Qualifications:
While not mandatory, possessing the following attributes would be advantageous:
- Advanced degree in engineering, life sciences, or a relevant field.
- Professional certifications in medical device regulations (e.g., ISO 13485 auditor).
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