Johnson & Johnson Karrieren

Staff Quality Engineer (d/f/m) Product Software Development

Philippsburg-Rheinsheim, Deutschland
Quality (Eng)


Requisition ID: 1905739071W

DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies will offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, 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. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.

Innomedic develops medical software for the Depuy Synthes business unit. This includes software tools and web applications to support the use of complex implants as well as the development of patient specific implants. Another focus is on development-supporting web applications and analysis tools for implant design. We are working in a regulated environment using cutting-edge tool chains to meet requirements of international standards.
Join our team working on groundbreaking products in medical technology.  
To strengthen our successful team at the location Philippsburg-Rheinsheim (between Heidelberg and Karlsruhe), we are looking for a

Staff Quality Engineer (d/f/m) Product Software Development

The Staff Quality Engineer will provide quality oversight for the development and maintenance of medical device software/systems. 

Your Tasks 
  • Participate and contribute to all phases of Software as a Medical Device (SaMD) development lifecycle.
  • Provide leadership, guidance and expertise on software development process, procedures and practices. 
  • Support internal and external audits of SaMD products and processes.
  • Provide expertise in applicable industry standards and regulations including, but not limited to as IEC 62304, FDA guidance, FDA Part 11, ISO13485, ISO14971, IEC 62366-1.
  • Provide technical support for audits of Software Suppliers and Software Consultants.
  • Support regulatory filings and inspections
  • Conduct training in Software Quality Systems / Software as a Medical Device

  • A minimum of a Bachelor’s Degree is required: in Engineering, Computer Science, Information Systems, Biomedical / Bioengineering Degree preferred
  • An Advanced Degree is preferred
  • A minimum of 8 years of regulated industry experience in a quality, new product development, or manufacturing engineering capacity is required. 
  • Medical device industry experience preferred
  • Process Excellence training resulting in Greenbelt or Blackbelt certification is preferred
  • ASQ certification as a Software Quality Engineer is preferred.
  • Successful Project and Team Leadership experiences are required
  • Additional experience in functional areas outside of Quality (e.g. IT, Engineering, NPD) is preferred
  • The ability to apply appropriate Quality tools/systems/processes to meet department goals and objectives is required
  • Demonstrated ability to effectively interdependently partner across functional areas/facilities is required
  • Demonstrated performance with managing cross-departmental projects is preferred
  • The ability to utilize written and oral communication skills to meet departmental goals/objectives is required
  • Demonstrated ability to prioritize and manage multiple projects while meeting deadlines/budgets is required
  • Demonstrated ability to develop and implement project plans, procedures and processes that result in positive business results are required
  • Extensive use and knowledge of personal computer and associated work tools is required
  • Good problem solving and decision-making skills
  • Good communication and team working skills
  • Ability to prioritize and manage multiple responsibilities
  • Assertive, target-driven and autonomous work approach
  • Good organisation skills
  • Commitment to excellent customer service
  • Very good knowledge of spoken and written English is essential
The well-being and development of our employees are central aspects of our company creed. Individuals who would like to fully realize their potential as part of our international, innovation-driven corporate family and who aspire to have challenging work, will find that our company provides just the right conditions. We consider intensive initial training, further education that is tailored to our employees' work and excellent opportunities for development - both nationally and internationally - to be just as essential as a good work-life balance, attractive compensation and above-average employee benefits. One aspect that distinguishes our company is the large number of measures we have to support our trainees and promote career development in ways that are also compatible with family life.

Primärer Standort
Deutschland-Baden Württemberg-Philippsburg-Rheinsheim-
Innomedic (7124)
Quality (Eng)
Requisition ID