We are currently looking for a Quality Engineer to support one of our clients in the medical device industry. The ideal candidate will provide quality support to production and ongoing projects, ensuring compliance with relevant quality and regulatory requirements (ISO 13485, 21 CFR part 820, 93/42 EEC).
Location: Le Locle, Canton de Neuchâtel, Switzerland
Workload: 100%, on-site role
Starting date: ASAP
Contract: Temporary unlimited contract via Randstad
Responsibilities
* Ensures that adequate Quality support is provided to productions and to open projects / initiatives
* Ensures that Nonconformances are initiated, dispositioned, approved and investigated according to plans and in compliance with procedures and regulatory requirements
* Ensures that quality activities for validation of new processes/ products are performed and documented according to procedures and within the defined timeline
* Write protocols and reports for validation documentation (such as process validation, test method validation, validation plan..)
* Ensures that risk analysis activities (PFMEA) are performed and documented according to procedures and within the defined timeline
* Organize meeting for risk analysis activities and write risk management documentation
* Ensures that GMP rules are known, understood and respected on the site
* Ensure technical support to QC and laboratory department
* Escalates quality issues and makes sure that appropriate actions are in place to fix the issue in a compliant manner
* Participates and supports internal and third party audits / inspections
* Manages or participates to quality projects
* Provides support to complaint investigation if required
* Participate to procedure elaboration or update
* Ensures that CAPA are managed and documented according to plans and in compliance with procedures
* Ensures support to process improvement projects
Job and Competencies requirements
* A minimum of a Bachelors Degree is required, preferable in Engineering, a Life Science or a related technical discipline.
* Experience working in a Medical Device manufacturing environment is preferred.
* Fluent in French and English
* Knowledge of Medical device standards and regulations such as ISO13485, 93/42 EEC, 21 CFR part 820
* Good communication, organizational, negotiation and interpersonal skills
* Good analytical problem-solving skills.
* Use of Agile, Oracle, EtQ, Minitab
* Use of Microsoft office tools
* Good knowledge of statistical techniques
If you are interested in this opportunity, please apply via Linkedin. We look forward to receiving your application!
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