quality engineer in Neuchâtel

Benoit Rochat, Geneva Professionals Health Care & Life Sciences
job type
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job details

life sciences
job type
reference number
benoit rochat, geneva professionals health care & life sciences
058 201 54 40

job description

Do you have a first experience with risk analysis in the Life Science industry? Do you like to work in a fast paced environment? You should then read the following lines!

One of our clients, specialised in the medical device industry, is looking for a:

Title: Quality Engineer

Location: Neuchâtel area

Contract: 12 months

Your tasks:

  • 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

  • Ensures that adequate Quality support is provided to productions and to open projects / initiatives

  • Writes protocols and reports for validation documentation (such as process validation, test method validation, validation plan..)

  • Ensures 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

  • Participates 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

  • Ensure resources are correctly filled in the project database

Your profile:

  • A minimum of a Bachelor's Degree is required, preferable in Engineering, in Life Science or a related technical discipline

  • Experience working in a Medical Device manufacturing environment is preferred

  • Knowledge of Medical device standards and regulations such as ISO 13485, 93/42 EEC, 21 CFR part 820

  • Good knowledge of statistical techniques

  • Good knowledge of risk analysis

  • Fluent in French and English

Those lines sound interesting ? Apply now!