Manager – Software Post-market Quality
| 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 engineering
- Minimum of 8 years of experience working within the medical device or Medical Technology industries.
- Minimum of 1 year of experience leading teams within a highly regulated industry in following cGMP and GDP regulations.
- Experience in post-market quality in overseeing Non-Conformances and Corrective Action and Preventative Action (NC/CAPA), managing product field actions, and handling customer complaints through systems such as Trackwise, SAP, Salesforce, or Zendesk.
Responsibilities
- Manage and develop a team of post-market quality engineers focused on customer quality initiatives for Software in a Medical Device (SiMD), Software as a Medical Device (SaMD), and medical devices within Stryker Medical’s Digital Health portfolio
- Drive product quality and compliance, partnering with Professional Service, Post Market, Technical Support and Research & Development (R&D) to prioritize projects, allocate resources, and provide customer excellence.
- Oversee post-market process improvements, ensuring compliance in software development, verification & validation, risk management, Non-Conformance and Corrective Action and Preventative Action (NC/CAPA), risk management and product security activities.
- Manage and execute risk management activities Software Failure Effects Analysis (sFMEA), risk documentation, product security, privacy and lead customer calls and discussions with partner teams to help resolve concerns.
- Approve quality documentation per Quality Management System (QMS) requirements.
- Track and report quality metrics to leadership, supporting management reviews and driving data-driven improvements.
- Lead internal and external compliance audits, ensuring findings are addressed while partnering with Regulatory Affairs to maintain global compliance (FDA, EU, EMEA, APAC) to support the business including sharing results and driving actions on findings.
- Responsible for managing and maintaining quality metrics for the customer quality activities, providing leadership updates in management reviews on projects and KPI’s as necessary.
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.