We are currently seeking a Quality Engineer for one of our clients in the Canton of Neuchatel.
If you are looking to work in a dynamic and very friendly working environment in the medical devices sector, then this is for you.
This is an open-ended temporary contract.
Please note this vacancy requires fluency in French.
Your Responsibilities:
1. Ensures that adequate Quality support is provided to productions and to open projects/initiatives.
2. Ensures that Non-Conformances are initiated, dispositioned, approved, and investigated according to plans and in compliance with procedures and regulatory requirements.
3. Ensures that quality activities for validation of new processes/products are performed and documented according to procedures and within the defined timeline.
4. Writes protocols and reports for validation documentation (such as process validation, test method validation, validation plan, etc.).
5. Ensures that risk analysis activities (PFMEA) are performed and documented according to procedures and within the defined timeline.
6. Organizes meetings for risk analysis activities and writes risk management documentation.
7. Ensures that GMP rules are known, understood, and respected on the site.
8. Ensure technical support to QC and laboratory department.
9. Escalates quality issues and makes sure that appropriate actions are in place to fix the issue in a compliant manner.
10. Participates and supports internal and third-party audits/inspections.
11. Provides support to complaint investigation if required.
12. Ensures that CAPA are managed and documented according to plans and in compliance with procedures.
13. Ensures support to process improvement projects.
Your Profile:
1. A minimum of a Bachelor Degree is required, preferably in Engineering, Life Science, or a related technical discipline.
2. Experience working in a Medical Device manufacturing environment is preferred.
3. Fluent in French and English.
4. Knowledge of Medical device standards and regulations such as ISO 13485, 93/42 EEC, 21 CFR part 820.
5. Good communication, organizational, negotiation, and interpersonal skills.
6. Good analytical problem-solving skills.
7. Use of Agile, Oracle, EtQ, Minitab.
8. Use of Microsoft Office tools.
9. Good knowledge of statistical techniques.
Those lines sound interesting? We are looking forward to receiving your application.
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