Quality Engineer

Our client, one of the biggest medical device companies in the world, is looking for a Quality Engineer to use their experience for effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle.

Main responsibilities:

• Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and Medical Device Directive (MDD) requirements) including providing support during internal and external audits.
• Partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges.
• Approve IQ, OQ, PQ, TMV or Software Validation
• Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
•  Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.

Main Requirements:

• Degree in a Life Sciences/ Biotechnology, Chemistry discipline or comparable work experience
• 3-5 years of experience working in Medical Devices
• Experience of quality activities in a GMP environment and good knowledge of related regulatory requirements in the life sciences industry (GAMP 5, 21 CFR part 11,...)
• Good verbal and written skills in English, German is a plus

If you would like to learn more about this opportunity, feel free to reach out to me at cogeoghegan@actalentservices.com.

Job Title: Quality Engineer

Location: Solothurn, Switzerland

Job Type: Contract

Aerotek and Actalent Services, an Allegis Group company. Allegis Group AG, Aeschengraben 20, CH-4051 Basel, Switzerland. Registration No. CHE-101.865.121. Aerotek and Actalent Services are companies within the Allegis Group network of companies (collectively referred to as "Allegis Group"). Aerotek, Actalent Services, Aston Carter, EASi, TEKsystems, Stamford Consultants and The Stamford Group are Allegis Group brands. If you apply, your personal data will be processed as described in the Allegis Group Online Privacy Notice available at https://www.allegisgroup.com/en-gb/privacy-notices.

To access our Online Privacy Notice, which explains what information we may collect, use, share, and store about you, and describes your rights and choices about this, please go to https://www.allegisgroup.com/en-gb/privacy-notices.

We are part of a global network of companies and as a result, the personal data you provide will be shared within Allegis Group and transferred and processed outside the UK, Switzerland and European Economic Area subject to the protections described in the Allegis Group Online Privacy Notice. We store personal data in the UK, EEA, Switzerland and the USA. If you would like to exercise your privacy rights, please visit the "Contacting Us" section of our Online Privacy Notice at https://www.allegisgroup.com/en-gb/privacy-notices for details on how to contact us. To protect your privacy and security, we may take steps to verify your identity, such as a password and user ID if there is an account associated with your request, or identifying information such as your address or date of birth, before proceeding with your request. If you are resident in the UK, EEA or Switzerland, we will process any access request you make in accordance with our commitments under the UK Data Protection Act, EU-U.S. Privacy Shield or the Swiss-U.S. Privacy Shield