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Product Quality Engineer

Product Quality Engineer

Distalmotion SAÉpalinges, VD, CH
Vor 7 Tagen
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Stellenbeschreibung

Join Us in Empowering Access to Robotic Surgery

At Distalmotion, we believe patients deserve best-in-class minimally invasive care. Our mission is to empower access to the benefits of robotic surgery. The DEXTER® Robotic Surgery System uniquely simplifies operations so more surgeons, in more ORs, can provide the benefits of robotics to more patients.

Whether in hospital outpatient departments (HOPDs), ambulatory surgical centers (ASCs), or traditional operating rooms, we are enabling more healthcare providers to deliver high-quality care by offering surgeons the choice to provide the best treatments to their patients.

We are a global MedTech company driven by Excellence, Thinking Big, a Can-Do mindset, Care, and Trust. These values guide our work as we develop solutions that remove barriers to robotic surgery access.

If you’re passionate about improving healthcare and want to be part of a highly innovative and exciting journey, join us in bringing novel solutions to market and expanding access to robotic surgery.

About Product Quality Engineer :

Support Product & Supplier Quality team integrated in QA / RA department on product quality activities, for Distalmotion (DM) products (sterile instruments, Dexter robot system and its accessories, other products used with Dexter system), manufactured at contracts manufacturers (CMO) and suppliers, as main activities, and partially supplier quality activities, as above described.

Duties and Responsibilities :

Product quality activities :

  • Manage and follow internal / process non conformities.
  • Define and participate on continuous improvements of DM products and processes.
  • Support on CAPA investigations and implementation of internal actions.
  • Collaborate on Product KPIs monitoring, data trend analysis and create Product Quality Reviews reports.
  • Collaborate on pFMEA / process validations documentation reviews.
  • Collaborate and follow on product release process.
  • Collabore on changes and design transfers to CMOs / suppliers.
  • Contribute on needed changes on ERP / QMS systems (new / update test plans, QA items configuration, QMS procedures, work instructions and forms).

Supplier Quality activities :

  • Manage and execute suppliers’ qualification audits according to audit plan.
  • Support new CMO / suppliers implementation according to DM requirements and procedure.
  • Support SQE on suppliers’ management activities according to standard DM procedure.
  • Manage nonconformities from suppliers (audits, incoming, production issues) and CAPA plans defined by suppliers and follow up.

    • Work Experience and Education requirements :

  • Bachelor’s degree in an engineering science (mechanical, electronics) or quality.
  • 3-4+ years’ experience in Supplier Quality, Quality Control, or Manufacturing engineering within the Medical device industry or similar.
  • Experienced / trained on ISO 13485 and 9001 standards and as external auditor on these standards.

    • Knowledge, Skills & Abilities required :

  • Experience in non-conformities and CAPA management.
  • Proven experience on KPI measurement, quality reports and data trending / analysis.
  • Manufacturing and engineering skills - knowledge of manufacturing and production processes, process enhancement (provide guidance on improving process efficiency while maintaining a high level of quality, safety, and reliability).
  • Excellent written and verbal in-house and external communication and liaison skills.
  • English Fluent, French & / or German a plus.
  • Open to travel – around 10% for partial supplier quality activities.

    • Benefits :

  • Opportunity to work in a fast-growing company active in one of the most promising fields of medicine.
  • A dynamic atmosphere in an internationally minded environment.
  • Permanent contract.
  • Other benefits : Mobility plan, competitive company pension plan, support for gym memberships.
  • Regular team building events such as boot camps, skiing and much more.

    • Distalmotion is a medical device company founded and based in Lausanne, Switzerland. It was founded in 2012, as a spin-off from the Robotics Lab of the Swiss Federal Institute of Technology in Lausanne (EPFL).Our objective is to remove the complexity out of robotic surgery in order to fast track its widespread adoption in minimally invasive care. To do so, we want to continue disrupting minimal invasive surgery - but we will only succeed with the right people on our team. Join our team to address critical healthcare needs and improve patients’ lives !

    For further information visit : www.distalmotion.com and follow us on LinkedIn / Twitter : @Distalmotion.

    Jobalert für diese Suche erstellen

    Quality Engineer • Épalinges, VD, CH