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. Ensure that adequate Quality support is provided to productions and to open projects/initiatives.
2. Ensure that Non-Conformances are initiated, dispositioned, approved, and investigated according to plans and in compliance with procedures and regulatory requirements.
3. Ensure that quality activities for validation of new processes/products are performed and documented according to procedures and within the defined timeline.
4. Write protocols and reports for validation documentation (such as process validation, test method validation, validation plan, etc.).
5. Ensure that risk analysis activities (PFMEA) are performed and documented according to procedures and within the defined timeline.
6. Organize meetings for risk analysis activities and write risk management documentation.
7. Ensure that GMP rules are known, understood, and respected on the site.
8. Provide technical support to QC and laboratory departments.
9. Escalate quality issues and ensure that appropriate actions are in place to fix the issue in a compliant manner.
10. Participate in and support internal and third-party audits/inspections.
11. Provide support to complaint investigations if required.
12. Ensure that CAPA are managed and documented according to plans and in compliance with procedures.
13. Ensure support to process improvement projects.
Your profile:
1. A minimum of a Bachelor’s Degree is required, preferably in Engineering, a 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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