80 days ago on jobs.jnj.com

Senior Quality Engineer - Product Software Development

Synthes GmbH

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Senior Quality Engineer - Product Software Development

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Senior Quality Engineer – Product Software Development

Standorte:Zuchwil, Schweiz
Funktion: Quality (Eng)
Requisition ID: 000016ZU

"Caring for the world… one person at a time”inspires and unites the people of Johnson & Johnson. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo


DePuy Synthes Companies of Johnson & Johnson is the largest, most comprehensive orthopedic and neurological business in the world. DePuy Synthes offer an unparalleled breadth and depth of technology, devices, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, cranio-maxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today’s evolving health care environment. Our broad array of inspired, innovative and high-quality offerings help advance the health and wellbeing of people around the world.


For the Quality Engineering department in Zuchwil (SO), we are looking for a Senior Quality Engineer – Product Software Development(m / f)


In this position you will have accountability supporting product software development and lifecycle management as well as the site Quality Manager in Rheinsheim, Philippsburg (Germany). Other tasks include:


  • Participate and contribute to all phases of software as a medical device (SaMD) development lifecycle
  • Ensure products are developed and maintained in accordance with applicable industry standards and regulations
  • Provide technical support for audits of Software Suppliers and Software Consultants
  • Support regulatory filings and inspections
  • Review and approve software development plans, risk assessments, technical reports and deliverables associated the Software Design History File (SDHF).
  • Maintaining the QMS with regards to current applicable standards and regulations
  • Corrective actions investigations
  • Quality Training
  • Travel to Philippsburg (Germany) will be required, 15%
  • International travel may be required, around 1 trip per year
  • University Degree in Computer Science, Engineering or equivalent studies
  • A minimum of 3-5 years’ experience in a regulated industry in quality assurance, new product development, or manufacturing engineering
  • Experience in the Medical Devices Industry is a must
  • Strong understanding of all regulations and normative requirements in regards to Medical Device Industry (ISO 13485, IEC 62304, ISO 14971 FDA QSR)
  • Experience with System Development Life Cycle for designing and developing of software and PEMS components to be intended as medical device or part of a medical device
  • Fluent in English and German
  • Able to solve conflicts and work independently in a challenging fast changing international work environment
  • Well organized, self-motivated, creative and pragmatic
  • Solution-oriented, process-oriented and a team player

If you are a creative and innovative mind passionate about medical technology and want to become part of a successful and growing organization, then please send us your online application (CV, Motivation Letter, Working References etc.)

Primärer Standort
Synthes GmbH (7111)
Quality (Eng)