Quality Engineer Product Quality

Job Title

The Staff Quality Engineer, Product Software Development, provides quality leadership on new product project teams responsible for the development of medical device software systems.

• Support the design, development and testing of Medical Device Software, including Software as a Medical Device (SaMD) products.
• Provide leadership, guidance and expertise on the software development process, procedures and practices.
• Enhance processes to better reflect state‑of‑the‑art practices and drive continuous improvement.
• Partner with R&D to refine requirements and ensure that architecture and design documents are comprehensive.
• Facilitate the documentation and tracking of verification activities, including code review findings.
• Review test case execution results and manage defects.
• Facilitate software risk assessment sessions and own the development of risk documents.
• Support regulatory filings and registrations.
• Support internal and external audits or inspections of SaMD products and processes and own non‑conformances or CAPAs and drive root cause investigations.
• Provide technical support for audits of software suppliers and software consultants.
• Conduct training on Medical Device Software development processes and quality systems.
• Train and mentor new engineers and lower‑level quality engineers.
• Provide expertise in applicable industry standards and regulations, including IEC 62304, FDA guidance, FDA Part
  11, ISO
  13485, EUMDR, ISO
  14971, IEC
  62366, ISO
  27001, and HIPAA.
• Provide guidance to project teams, suppliers and other disciplines to ensure compliance with company policies and medical device regulations.
• Ensure that patient ePHI and PII data are protected and security requirements are met.
• Incorporate and comply with all applicable laws and regulations related to DePuy Synthes business activities and policies and procedures for Health Care Compliance Program and Code of Conduct.
• Communicate business related issues or opportunities to next management level.
• Follow all company guidelines related to health, safety and environmental practices as applicable.
• For those supervising staff, ensure subordinates follow all company guidelines related to health, safety and environmental practices and that all needed resources are available.
• Ensure personal and company compliance with all federal, state, local and company regulations, policies, and procedures.

A bachelor’s degree or university degree is required; an advanced degree is preferred. Degrees in Engineering, Computer Science, Information Systems or Biomedical/Bio‑engineering are preferred.

Minimum of 6 years of regulated industry experience in quality, new product development or manufacturing engineering is required. Experience with the development of Software as a Medical Device (SaMD) or System Development Life Cycle (SDLC) for medical device software is strongly preferred.

Prior experience leading, coaching or mentoring other engineers or core team members is required. Demonstrated ability to lead, synchronize and motivate personnel both within and outside immediate control to meet goals and objectives. Ability to meet departmental goals/objectives is required.

Demonstrated ability to prioritize and manage multiple projects while meeting deadlines and budgets is required. Additional experience in functional areas outside of Quality (e.g. IT, Engineering, Software Development) is desired. Ability to perform duties in accordance with policies and procedures and to comply with civil rights requirements.

• Ability to work in a team and demonstrate good interpersonal, organizational, and verbal/written communication skills.
• Extensive use of the personal computer and associated work tools (Word, Excel, Power Point) is required.
• Medical device industry experience.
• ASQ Certification as a Software Quality Engineer, or equivalent, is preferred.
• Skills:
  
  Agility, Analytical Reasoning, Coaching, Collaboration, Critical Thinking, Model‑Based Systems Engineering (MBSE), Product Design, Report Writing, Requirements Analysis, Research and Development, SAP Product Lifecycle Management, Scripting Languages,…