QA Engineer MDR

Vor 5 Tagen

Basel, Basel-Stadt, Schweiz skilltec Vollzeit CHF 80'000 - CHF 120'000 pro Jahr

Responsibilities:

  • Build and maintain certified MDR Quality Management System
  • • Lead product registration process with Notified Body
  • • Represent the QMS as deputy PRRC
  • • Maintain local training compliance
  • • Lead and participate in internal audits
  • • Provide Quality related trainings
  • • Organize site Management Review
  • • Track and report KPIs
  • • Supplier qualification including leading of audits
  • • Site QARA projects

Skills Required:

  • Bachelor's degree in Life Science or equivalent
  • • Minimum of 5 years' experience in Regulatory Affairs, Clinical Affairs or Quality Assurance
  • • Record of success and broad understanding of contemporary quality practices as they apply to product development,
  • manufacturing, and commercial operations
  • • Proven expertise in the design and implementation of quality processes in world-class medical device manufacturing
  • organization under MDR regulation
  • • Expertise in MDR, cGMP and other Regulatory compliance requirements
  • • Experience in software development in the medical device context
  • • Self-confidence and the ability to work with all levels of organization
  • • Operates in a way that never compromises ethics and integrity
  • • Advanced leadership skills
  • • Ability to understand and adapt to different cultures and market needs
  • • (Inter-)national travel as required by business (up to 10%)

  • QA Engineer

    Vor 3 Tagen

    Basel, Basel-Stadt, Schweiz ALTOGEN AG Vollzeit

    In 10 years, the Efor Group has reached the leading position in Life Sciences consulting with strong, synergic and strategic acquisitions. Our ambition is to build a global leading position of our market in 2028.In Switzerland, we work with 300 experts who support our customers on their various projects in the French-speaking and German-speaking parts of the...

  • QA qualification engineer

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz agap2 - HIQ Consulting Vollzeit CHF 80'000 - CHF 120'000 pro Jahr

    agap2 is a European engineering and operational consulting group founded in 2005 and specialized in the industry. We work in the Pharma, Biotechnology, Medical Devices, Energy, Infrastructure, Transportation, Chemicals, and Information Technology sectors.As a consultant, you will have to support our clients in the realization of their projects on site by...

  • Automation Engineer

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz X4 Life Sciences Vollzeit CHF 100'000 - CHF 120'000 pro Jahr

    Senior DeltaV Engineer - Long-Term ContractI'm partnering with a major biopharma manufacturer on alarge-scale DeltaV Batch project, and we're looking for an experiencedSenior DeltaV Engineerto join the team.If you have strongDeltaV Batch,GMP, andUpstream/Downstream processexperience, this is a great opportunity to step into a highly technical, visible role...

  • Automation Engineer

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz Roche Vollzeit CHF 80'000 - CHF 120'000 pro Jahr

    At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure...

  • Project Engineer

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz agap2 - HIQ Consulting Vollzeit CHF 80'000 - CHF 120'000 pro Jahr

    agap2 is a European engineering and operational consulting group founded in 2005 and specialized in the industry. We work in the Pharma, Biotechnology, Medical Devices, Energy, Infrastructure, Transportation, Chemicals, and Information Technology sectors.As a consultant, you will have to support our clients in the realization of their projects on site by...

  • ICT Engineer

    vor 19 Stunden

    Basel, Basel-Stadt, Schweiz R&D Partners Vollzeit CHF 80'000 - CHF 120'000 pro Jahr

    Drive innovation and safeguard IT excellence as an ICT Engineer in Basel's leading pharmaceutical hub.R&D Partners is seeking anICT Engineerto join a leading pharmaceutical company in Basel. This role offers the opportunity to work in a dynamic and innovative environment, supporting IT infrastructure and ensuring seamless operations within a GMP...

  • Senior Design Engineer – Medical Device Development

    Vor 3 Tagen

    Basel, Basel-Stadt, Schweiz Novartis AG Vollzeit CHF 120'000 - CHF 180'000 pro Jahr

    Job ID REQ Okt 31, Schweiz Summary Location: Basel, Switzerland #onsite Role Purpose: At Novartis, we are reimagining medicine to improve and extend people's lives. We discover and develop breakthrough treatments and find new ways to bring cures to as many people as possible. Without safe, easy-to-use, high-quality drug delivery devices our patients could...

  • Senior Design Engineer – Medical Device Development

    Vor 5 Tagen

    Basel, Basel-Stadt, Schweiz Novartis Vollzeit CHF 120'000 - CHF 180'000 pro Jahr

    Job Description SummaryLocation: Basel, Switzerland #onsiteRole Purpose:At Novartis, we are reimagining medicine to improve and extend people's lives. We discover and develop breakthrough treatments and find new ways to bring cures to as many people as possible. Without safe, easy-to-use, high-quality drug delivery devices our patients could not get their...

  • Development Engineer SDIS

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz Straumann Group Vollzeit CHF 80'000 - CHF 120'000 pro Jahr

    Headquartered in Basel, Straumann is a global leader in implant and restorative dentistry and oral tissue regeneration. Having pioneered many of the most influential technologies and tech-niques in our field, we have a tradition of doing more to advance dental regeneration, restora-tion and replacement, as well as patient care. Straumann partners with...

  • Senior Device Engineer

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz Roche Vollzeit CHF 100'000 - CHF 120'000 pro Jahr

    At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure...