QA engineer Pharma Biotech Medical Device

Capgemini Engineering is part of the Capgemini Group, a responsible, multicultural global leader with 270,000 people in nearly 50 countries. Capgemini Engineering is a strategic partner to companies as they transform their businesses by leveraging the full power of technology. The Group achieved revenues of €16 billion in 2020. Capgemini Engineering is the brand of the Capgemini Group bringing together engineering and R&D services. Capgemini Engineering employs over 52,000 engineers and scientists in more than 30 countries, in sectors such as life sciences, aeronautics, automotive and rail.

Capgemini Engineering operates in Switzerland and globally with offices in Zurich, Basel, Lausanne and Geneva and has over 400 expert consultants in all sectors.

Our offer

To strengthen our team in Switzerland we are looking for Quality Assurance Consultants.

As a Quality Consultant you will provide our clients with the necessary expertise and assistance to further improve and maintain the quality standards for their operations and products.

 

Your role

You will be involved in:

- Initiating improvements to the Quality Management System, ensuring compliance to all relevant quality standards and regulatory requirements.
- Handling customer complaints.
- Investigating deviations and non-conformities in cross-functional teams.
- CAPA and risk analysis
- Reviewing batch records and release. 

- Review and proactively assist in process capability studies and statistical techniques as required, to support continuous improvement.

 

Your profile

Education level:

Master or Engineering Degree in quality engineering (EPFL, ETH, HES or equivalent) with emphasis on Pharma- and/or Biotech- and/or Medical Engineering.

 

Requirements:

- Minimum 2 years of experience in Quality Assurance.
- Applied knowledge of FDA or Swissmedic and international Pharmaceutical and or medical device regulations (ISO 13485, 21 CFR 820, etc.).
- Applied technical understanding of manufacturing equipment; processes specific to pharmaceutical, biotech and or medical device manufacturing.

Languages: French and English fluent mandatory.

 

Key qualities:

- You know how to take initiative
- You like to work in a multidisciplinary team
- You value knowledge-sharing
- You must have strong verbal and writing communication capabilities.