What are the responsibilities and job description for the Manager, Post-market Quality position at Stryker Sports Medicine?
Stryker is hiring a Manager, Post-market Quality to manage a team of post market Quality Assurance engineers that work on Software as a Medical Device (SiMD) or Software in a Medical Device (SiMD) for our Digital Health solutions for our medical division for post-market projects. This team collaborates with Professional Services, Technical Support, and Post-Market Quality teams to address customer complaints, manage product field actions, oversee customer communications, and support release management, ensuring a strong customer quality framework.
Workplace Flexibility & Location requirements: This is a hybrid role requiring the candidate to be within commuting distance of one of the following locations: San Jose, CA, Portage, MI, Kalamazoo, MI or Fort Wayne, IN. The work schedule is structured to support flexibility, with in-office presence required Monday through Wednesday and remote work available on Thursday and Friday. To qualify, candidates must be able to commute to one of these specific facilities as needed. Relocation assistance is approved for eligible candidates.
What You Will Do
What you need:
Workplace Flexibility & Location requirements: This is a hybrid role requiring the candidate to be within commuting distance of one of the following locations: San Jose, CA, Portage, MI, Kalamazoo, MI or Fort Wayne, IN. The work schedule is structured to support flexibility, with in-office presence required Monday through Wednesday and remote work available on Thursday and Friday. To qualify, candidates must be able to commute to one of these specific facilities as needed. Relocation assistance is approved for eligible candidates.
What You Will Do
- 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.
What you need:
- 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.
- 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.
