Manager, Post-market Quality
Stryker is hiring a Manager, Post-market Quality to manage a team of post market Quality Assurance engineers that work on SaMD/SiMD for our Digital Health solutions for our Medical division for post-market projects.?
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, 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:
? Manages a team of quality engineers that work on customer quality activities to support Software as a Medical Device (SaMD) products for Medical's Digital Health portfolio Partners with the Professional Services/Technical Support/Post Market Quality teams to drive customer quality.
? Lead and develop a team of quality engineers supporting SiMD, SaMD, and medical devices within Stryker Medical's Digital Health portfolio to resolve customer complaints/product field actions/customer communications/release management.
? Drive product quality and compliance, partnering with Professional Service, Post Market, Technical Support and 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, NC/CAPA/risk management and product security activities.
? Manage and execute risk management activities (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:
Required Qualifications:
? Bachelors degree in an Engineering discipline.
? Minimum 8+ years? of professional experience working within the Medical device industry.
? Minimum of 1-3 years of experience leading teams in a highly regulated, matrixed environment, with a focus on post-market customer quality.
? Experience managing non-conformances (NC/CAPA), product field actions, and customer complaint processes (e.g., Trackwise, SAP, Salesforce, Zendesk).
Preferred Qualifications:
? Experience and knowledge of 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.
115,600.00 to 245,800.00 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.
Apply Now
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, 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:
? Manages a team of quality engineers that work on customer quality activities to support Software as a Medical Device (SaMD) products for Medical's Digital Health portfolio Partners with the Professional Services/Technical Support/Post Market Quality teams to drive customer quality.
? Lead and develop a team of quality engineers supporting SiMD, SaMD, and medical devices within Stryker Medical's Digital Health portfolio to resolve customer complaints/product field actions/customer communications/release management.
? Drive product quality and compliance, partnering with Professional Service, Post Market, Technical Support and 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, NC/CAPA/risk management and product security activities.
? Manage and execute risk management activities (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:
Required Qualifications:
? Bachelors degree in an Engineering discipline.
? Minimum 8+ years? of professional experience working within the Medical device industry.
? Minimum of 1-3 years of experience leading teams in a highly regulated, matrixed environment, with a focus on post-market customer quality.
? Experience managing non-conformances (NC/CAPA), product field actions, and customer complaint processes (e.g., Trackwise, SAP, Salesforce, Zendesk).
Preferred Qualifications:
? Experience and knowledge of 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.
115,600.00 to 245,800.00 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.
Apply Now