Johnson & Johnson Karrieren
Quality Engineering Manager - Product Software Development (d/f/m)
Requisition ID: 1905738594W
- 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
- 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