Quality Manager – Software Design Assurance
| Company | Stryker |
|---|---|
| Location | San Jose, CA, USA, Portage, MI, USA, Kalamazoo, MI, USA, Fort Wayne, IN, USA |
| Salary | $115600 – $245800 |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Senior, Expert or higher |
Requirements
- Bachelor’s degree in Science, Engineering or related discipline.
- Minimum of 8 years’ experience working within the medical device or Technology industries.
- Experience in product design quality and software risk management, including Software Failure Modes and Effects Analysis (sFMEA) and design control processes (SAFe or Agile).
- Experience in software change management, release management, and defect management in using tools such as Jama, Confluence, DOORS, Enzyme, Bitbucket, Jira, or GitHub.
Responsibilities
- Manage and develop a team of design quality engineers supporting Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) and other medical devices within Stryker Medical’s Digital Health portfolio.
- Collaborate with Marketing, Project Management Organization (PMO), and Research & Development (R&D) to drive product quality to prioritize projects, allocate resources, and make strategic decisions that enhance product quality.
- Oversee product development, verification, validation, risk management, and product security to ensure compliance while driving continuous process improvements.
- Lead and manage risk management activities Design Failure Modes and Effects Analysis (dFMEA), Software Failure Modes and Effects Analysis (sFMEA), risk documents, product security, privacy) and approve quality documentation per QMS requirements.
- Track, monitor & report of the design and development of quality metrics, providing updates in management reviews as needed.
- Lead and support internal & external audits and regulatory compliance, drive actions on findings, and partner with Regulatory Affairs to meet global compliance requirements (FDA, EU, EMEA, APAC).
- Recruit, develop, train, and mentor top talent while fostering growth, engagement, and development through assignments and coaching.
- Define team objectives in alignment with business and Regulatory Affairs and Quality Assurance (RAQA) goals, providing guidance, performance feedback, and career development opportunities.
Preferred Qualifications
- Experience with US and International Medical Device Regulations (820/IEC 62304/IEC 82304/60601), with experience in Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), and/or Digital Health Systems and Telehealth Solutions.
- Experience in participating in both internal and external audits, including direct interaction with regulatory agencies such as the FDA, MoH, and TUV.
- Experience with software technologies for mobile, cloud, or AI/ML solutions (e.g., AWS, Azure, Apple, Android) and their applications in Telehealth, Healthcare IT, or Virtual Nursing solutions.