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Johnson & Johnson Karrieren

Quality Engineering Manager - Product Software Development (d/f/m)

Philippsburg-Rheinsheim, Deutschland
Quality (Eng)


Arbeitsplatzbeschreibung

Requisition ID: 1905738594W

 
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

Quality Engineering Manager (d/f/m)

The Quality Engineering Manager will be responsible for implementing and maintaining the Software as a Medical Device QMS and will provide quality oversight forthe development and maintenance of medical device software/systems. He/she will provide leadership and talent management to direct reports. This individual will provide technical contribution in a team environment.

Your Tasks
  • Provide leadership, guidance and expertise on software development process, procedures and practices.
  • Provide expertise in applicable industry standards and regulations including, but not limited to IEC 62304, FDA guidance, FDA Part 11, ISO13485, ISO14971, and IEC62366-1.
  • Provide technical support for audits of Software Suppliers and Software Consultants.
  • Maintain Product Software and Software as a Medical Device (SaMD) development procedures.
  • Support regulatory filings and inspections
  • Perform all job duties in full accordance with the Worldwide Policies 
  • Manage Direct Report(s) and oversee their projects to insure compliance to local procedures and regulatory requirements.
  • Connect with counterparts within DePuy Synthes and other Johnson & Johnson business units to benchmark, standardize, and leverage best practices.
  • Conduct training in Software Quality Systems/ Software as a Medical Device
 


Qualifikationen

  • 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
  • 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-
Organisation
Innomedic (7124)
Funktion
Quality (Eng)
Requisition ID
1905738594W