
Medical Device Assurance Specialist
4 days ago
We are seeking a highly skilled Senior Device Engineer to spearhead medical device audits and assessments, ensuring compliance with relevant regulations.
Responsibilities:- Conduct thorough audits of medical devices to guarantee adherence to ISO 13485, MDD 93/42/EEC, and IMDR standards.
- Collaborate effectively with cross-functional teams to achieve shared goals.
- Utilize EN ISO 14971 to proactively identify and mitigate risks associated with medical devices.
- Possess in-depth knowledge of non-active devices and sterilization processes.
- At least 10 years of professional experience in the medical devices industry or related fields.
- A minimum of 5 years of relevant experience in quality management is essential.
To succeed in this role, you should be a motivated and detail-oriented individual who can drive our team's success. If you possess the necessary skills and qualifications, please submit your updated CV for consideration.
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