Medical Device Validation Consultant

vor 3 Wochen

Basel, Schweiz wega Informatik Vollzeit

We are a Pharma and Life Science IT service provider that has been successfully carrying out 'state-of-the-art' projects for international customers for 30 years, now. Our consultants work in
- our office in Basel
- from home
- on our customer’s premises

We are a dynamic forward-thinking and expanding organization with a great team spirit and always on the look out for like-minded individuals. If you are driven by ambition and highly motivated by challenging jobs, as well as financial incentives, you have come to the right place.

With our attractive compensation and fringe benefits model, this is a great opportunity to maximize your earning potential. The further development of our colleagues and team members coupled with an excellent work atmosphere are amongst the top values of our company.

**Your Area of Responsibilities**:

- Act as a consultant in various Medical Device validation projects for our SaMD customers and other customers in the life science industry
- Develop tailor made validation strategies for the customers, mainly with agile validation concepts
- Contribute to the development of wega in the medical device area
- Responsible for project delivery, coordination of project activities, training of project teams
- Responsible for the creation of validation deliverables, incl. coordination with customer or external resources to ensure consistency and quality overall
- Interact with all (customer) project stakeholders as a project member
- Support customers to reach inspection readiness
- Perform Medical Device related audits
- Act as coach for more junior wega consultants in the Medical Device area
- Active cooperation in wega internal networks (e.g. Medical Device, CSV, Agile Validation, Templates, Test Automation, regulations and technology related topics)
- Develop and conduct Medical Device validation training for wega as well as for customers

**Your Experience & Qualifications**:

- More than 5 years experience in the Medical Device area, SW Quality Management, SW Testing, CSV or another quality assurance area within a regulated industry
- Advanced knowledge of SaMD, MDR, 21 CFR Part 820, ISO13485, ISO14971, IEC62304, IEC62366 and other standards. Experience in other regulated domain(s) desirable as well
- Experience with Artificial Intelligence Quality and Certification would be a big plus (e.g. Good Machine Learning Practice from FDA)
- Excellent communication skills, very good written and spoken English and German, French is a plus
- Independent, highly self-organized (multi project assignments in parallel) and intrinsic motivated in sharing knowledge
- Willingness to travel (up to 20%)
- Experience with Test Management Tool(s) is a plus (e.g. Microfocus ALM, code beamer, JIRA/Xray)

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