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Senior Quality Assurance Engineer
Il y a 3 mois
In the role of Senior Quality Assurance Engineer - Medical Devices, your primary responsibilities will include:
* Collaborating with Research & Development, Manufacturing Engineers, and production teams,
* Designing and executing enhancements to processes and systems aimed at improving safety, quality, and compliance,
* Assisting the team with the change control procedures,
* Facilitating component qualification processes (initial samples/first article approval),
* Overseeing the review and endorsement of testing protocols and reports related to process validation,
* Directing the management of deviations and non-conformities,
* Addressing internal and supplier reports concerning non-conforming materials,
* Leading or participating in corrective and preventive action initiatives (CAPA).
The ideal candidate for the Senior Quality Assurance Engineer - Medical Devices position should possess:
- A minimum of a Master's degree in engineering,
- At least a decade of experience within the medical device sector,
- Familiarity with inspection and testing standards,
- A solid understanding of risk management principles and ISO 14971,
- Knowledge of quality management systems for medical devices as per ISO 13485,
- Proficiency in statistical analysis.
Michael Page Santé specializes in the pharmaceutical sector, biomedical field, biotechnology, and healthcare institutions. We focus on recruiting seasoned professionals for positions in Pharmacy, production and R&D, sales and marketing, and healthcare management.
We are seeking a Senior Quality Assurance Engineer - Medical Devices for our client.
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