Johnson & Johnson Careers
Staff Quality Engineer, Product Software Development
Requisition ID: 0336190326
DePuy Synthes Companies, a member of Johnson & Johnson's Family of Companies, is recruiting for a Staff Quality Engineer, Product Software Development. This position may be based out of the following sites in West Chester, PA; Warsaw, IN; Raynham, MA; Somerville, NJ; Cincinnati, OH, or various locations in Germany and Switzerland.
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.
The Staff Quality Engineer, Product Software Development, will provide quality oversight for the development and maintenance of medical device software/systems. This individual will provide technical contribution in a team environment.
- 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
- Perform all job duties in full accordance with the Worldwide Policies on Information Asset Protection, maintain password(s) as Confidential, and protect Critical Business Information.
- He/she will be required to know, understand, incorporate and comply with all applicable laws and regulations relating to Depuy Synthes business activities and Policies and Procedures of the Health Care Compliance Program and Code of Conduct.
- A minimum of a Bachelor’s Degree is required.
- A Bachelor’s Degree in Engineering, Computer Science, Information Systems, Biomedical/Bioengineering Degree preferred.
- An Advanced Degree is preferred.
- A minimum of 6 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 required.
- 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 is required.
- Extensive use and knowledge of personal computer and associated work tools (Word, Excel, Power Point) is required.
This position may be based out of the following sites in West Chester, PA; Warsaw, IN; Raynham, MA; Somerville, NJ; Cincinnati, OH, or various locations in Germany or Switzerland. This role requires up to 10% travel.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-Pennsylvania-West Chester-
Europe/Middle East/Africa-Switzerland-Basel-Country-Oberdorf, Europe/Middle East/Africa-Switzerland-Solothurn-Zuchwil, North America-United States-New Jersey-Somerville, North America-United States-Indiana-Warsaw, North America-United States-Ohio-Cincinnati, North America-United States-Massachusetts-Raynham, Europe/Middle East/Africa-Germany-Baden Württemberg-Philippsburg-Rheinsheim
Depuy Orthopaedics. Inc. (6029)