Johnson & Johnson Karrieren
Staff Quality Engineer (d/f/m) Product Software Development
Requisition ID: 1905739071W
- 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