Job Description
We are seeking a Quality Engineer for a client in the Canton of Neuchatel, working in the medical devices sector.
This is a temporary contract with an open-ended duration.
Fluency in French is required.
Your Responsibilities:
* Provide Quality support to production and open projects/initiatives.
* Initiate, dispose, approve, and investigate Non-Conformances according to plans and regulatory requirements.
* Perform quality activities for validation of new processes/products, documented according to procedures and within defined timelines.
* Write protocols and reports for validation documentation, such as process validation, test method validation, and validation plans.
* Ensure risk analysis activities (PFMEA) are performed and documented according to procedures and within defined timelines.
* Organize meetings for risk analysis activities and write risk management documentation.
* Ensure compliance with GMP rules on site.
* Provide technical support to QC and laboratory departments.
* Escalate quality issues and ensure appropriate actions are taken to fix the issue in a compliant manner.
* Participate in and support internal and third-party audits/inspections.
* Manage or participate in quality projects.
* Support complaint investigation if required.
* Participate in procedure elaboration or update.
* Ensure CAPA are managed and documented according to plans and procedures.
* Support process improvement projects.
Your Profile:
* Bachelor's degree in Engineering, Life Science, or related technical discipline required.
* Experience in Medical Device manufacturing environment preferred.
* Fluent in French and English.
* Familiarity with Medical device standards and regulations, such as ISO13485, 93/42EEC, 21 CFR part 820.
* Good communication, organizational, negotiation, and interpersonal skills.
* Good analytical problem-solving skills.
* Awareness of Agile, Oracle, EtQ, Minitab, and Microsoft Office tools.
* Knowledge of statistical techniques.