Medical Device Validation Consultant

vor 4 Monaten

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)

  • Medical Device Specialist

    vor 2 Monaten

    Basel, Basel-Stadt, Schweiz Roche Vollzeit

    About the RoleRoche is seeking a highly skilled Device Engineer to join our Device Development Department within Roche Technical Development. As a key member of our team, you will play a crucial role in the development and support of drug delivery devices for our product portfolio.Key ResponsibilitiesLead projects to successfully bring combination products...

  • Medical Device Supply Chain Manager

    vor 4 Wochen

    Basel, Basel-Stadt, Schweiz Novartis Vollzeit

    Job DescriptionNovartis is seeking a highly skilled and experienced professional to join our Global Device Compliance, Systems and Operations Team. As a key member of this team, you will play a critical role in accelerating our diverse and innovative medical device and drug-device combination product portfolios.Key Responsibilities:Use and maintenance of the...

  • Device Development Specialist

    vor 2 Monaten

    Basel, Basel-Stadt, Schweiz Roche Vollzeit

    The RoleRoche is seeking a skilled Device Engineer to join our Device Development Department within Roche Technical Development. As a Device Engineer, you will play a crucial role in the development and support of drug delivery devices for our product portfolio.Key ResponsibilitiesLead projects to successfully bring combination products and medical devices...

  • Medical Device Expert with Clinical Interest

    vor 5 Monaten

    Basel, Schweiz ColtèneWhaledent AG Vollzeit

    **Description**: COLTENE is a global leader in dental consumables and small equipment covering the whole dental treatment process. The company is headquartered in Altstätten, Switzerland, with state-of-the-art production facilities in Switzerland, the United States, Germany and Canada. We are looking for a new employee as a **Medical Device Expert with...

  • Device Engineer

    vor 5 Monaten

    Basel, Schweiz Roche Vollzeit

    The Position The Device Development Department within Roche Technical Development is responsible for the development and support of drug delivery devices for the product portfolio. Our activities span a range of engineering disciplines from the requirements definition phase through to commercialization and marketed product support. Roche is...

  • MES Consultant

    vor 4 Wochen

    Kanton Basel-Stadt, Schweiz Coopers Group AG Vollzeit

    MES Consultant Are you an IT Expert with a focus on MES systems within the Pharma or Medical Device industry? Are you willing to take on your next challenge in Switzerland? Then you might be interested in one of the projects for our clients in the area of Basel, Zug and Visp. As MES Expert, you will play a key role in making MES systems operating...

  • Mes Consultant

    vor 2 Monaten

    Kanton Basel-stadt, Schweiz Coopers Group AG Vollzeit

    MES Consultant Are you an IT Expert with a focus on MES systems within the Pharma or Medical Device industry? Are you willing to take on your next challenge in Switzerland? Then you might be interested in one of the projects for our clients in the area of Basel, Zug and Visp. As MES Expert, you will play a key role in making MES systems operating...

  • Mes Consultant

    vor 7 Monaten

    Basel, Schweiz Coopers Group AG Vollzeit

    MES Consultant Are you an IT Expert with a focus on MES systems within the Pharma or Medical Device industry? Are you willing to take on your next challenge in Switzerland? Then you might be interested in one of the projects for our clients in the area of Basel, Zug and Visp. As MES Expert, you will play a key role in making MES systems operating...

  • Technical Services Specialist

    vor 3 Wochen

    Basel, Basel-Stadt, Schweiz ResMed Vollzeit

    Job DescriptionWe are seeking a skilled Technical Services Specialist to join our team in Basel, Switzerland.Key Responsibilities:Repair and maintenance of medical devicesTechnical incoming goods inspection of medical devicesFault analysis and assessment of defective devices and assembliesPreparation of repair reports, test and measurement...

  • Cleaning Validation Expert

    vor 2 Monaten

    Basel, Schweiz ALTOGEN AG Vollzeit

    **ALTOGEN SWITZERLAND** is a Swiss engineering and consulting company specialized in life sciences with proven expertise in pharmaceuticals, biotechnology, medical devices. Since December 2023, Altogen Switzerland is part of the the EFOR group. With several years of experience, technical expertise and project coordination, we support our partners throughout...

  • MES Consultant

    vor 6 Monaten

    Kanton Basel-Stadt, Schweiz Coopers Group AG Vollzeit

    MES Consultant Are you an IT Expert with a focus on MES systems within the Pharma or Medical Device industry? Are you willing to take on your next challenge in Switzerland? Then you might be interested in one of the projects for our clients in the area of Basel, Zug and Visp. As MES Expert, you will play a key role in making MES systems operating...

  • MES Consultant

    vor 6 Monaten

    Kanton Basel-Stadt, Schweiz Coopers Group AG Vollzeit

    MES Consultant Are you an IT Expert with a focus on MES systems within the Pharma or Medical Device industry? Are you willing to take on your next challenge in Switzerland? Then you might be interested in one of the projects for our clients in the area of Basel, Zug and Visp. As MES Expert, you will play a key role in making MES systems operating...

  • MES Implementation Specialist

    vor 3 Wochen

    Basel, Basel-Stadt, Schweiz Coopers Group AG Vollzeit

    MES Consultant Job DescriptionWe are seeking an experienced MES Consultant to join our team at Coopers Group AG.Key Responsibilities:Implement and integrate MES systems to support production, quality, and compliance.Customize and configure MES systems to meet client needs.Provide end-user support and training.Ensure validation, risk management, and quality...

  • Device Development Engineer

    vor 1 Monat

    Basel, Basel-Stadt, Schweiz Roche Vollzeit

    Job Title: Device EngineerRoche is seeking a highly skilled Device Engineer to join our Device Development Department within Roche Technical Development. As a Device Engineer, you will be responsible for the development and support of drug delivery devices for our product portfolio.Key Responsibilities:Lead projects to successfully bring combination products...

  • Device Development Specialist

    vor 2 Monaten

    Basel, Basel-Stadt, Schweiz Roche Vollzeit

    Job Title: Device EngineerRoche is seeking a skilled Device Engineer to join our Device Development Department within Roche Technical Development. As a Device Engineer, you will play a crucial role in the development and support of drug delivery devices for our product portfolio.Key Responsibilities:Lead projects to successfully bring combination products...

  • Device Development Engineer

    vor 3 Wochen

    Basel, Basel-Stadt, Schweiz Roche Vollzeit

    The RoleRoche is seeking a highly skilled Device Engineer to join our Device Development Department. As a key member of our team, you will be responsible for the development and support of drug delivery devices, including Prefilled Syringes with Needle Safety Devices, Autoinjectors, and high-volume Patch-injectors.Key ResponsibilitiesLead projects to...

  • Device Development Engineer

    vor 4 Wochen

    Basel, Basel-Stadt, Schweiz Roche Vollzeit

    Job Title: Device EngineerRoche is seeking a highly skilled Device Engineer to join our Device Development Department within Roche Technical Development.Job Summary:The successful candidate will be responsible for the development and support of drug delivery devices for our product portfolio. This includes the design, engineering, testing, and manufacturing...

  • Device Development Specialist

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz Roche Vollzeit

    The RoleRoche is seeking a highly skilled Device Engineer to join the Device Development Department within Roche Technical Development. The successful candidate will be responsible for the development and support of drug delivery devices for the product portfolio.The Device Engineering group performs combine design, engineering, testing, and manufacturing to...

  • Device Development Specialist

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz Roche Vollzeit

    The RoleWe are seeking a highly skilled Device Engineer to join our team at Roche Technical Development, specifically within the Device Development Department.This department is responsible for the development and support of drug delivery devices for our product portfolio, covering a range of engineering disciplines from requirements definition to...

  • Senior IT Business Analyst

    vor 4 Wochen

    Basel-Stadt, Schweiz Coopers Group AG Vollzeit

    Senior IT Business Analyst (medical device or pharmaceutical industry) - ENG/GERAre you an experienced Senior Business Analyst looking for a new challenge in the pharmaceutical or medical device industry? Our client, a leader in the sector, is seeking a driven professional to help bridge the gap between IT and business objectives, particularly in the...