Stryker is seeking a Staff Software Quality Engineer, Post Market to support its Medical’s Digital Health division and portfolio of Software as a Medical Device (SaMD)/Software in a Medical Device (SiMD) and non-medical device software. The role aims to drive customer quality by overseeing ongoing compliance, monitoring performance, and driving continuous improvement for both regulated and non-regulated software medical products after market release.
Requirements
- Bachelor’s degree in science or engineering.
- Minimum of 4 years of experience working in the areas of Research & Development (R&D), Quality (QA/QC), Information Technology, Healthcare IT, Regulatory Affairs (RA) or Technology industry.
- Experience in software technical support resolution ensuring compliance with industry standards in handling Non-Conformances and Corrective Action and Preventative Action (NC/CAPA).
- Experience with software Failure Modes Effect Analysis (sFMEA), Security Risk Assessments and defect management, software testing and/or verification/validation.
- Knowledge of software development life cycle (SDLC), software validation, and agile methodologies.
- Experience in software technical support resolution within the medical device industry, ensuring compliance with regulatory standards such as FDA 21 CFR Part 820, ISO 13485, and IEC 62304, including handling Non-Conformances and Corrective Action and Preventative Action (NC/CAPA).
- Experience with digital health platforms, cloud infrastructure, and/or cybersecurity.
Responsibilities
- Collaboratively ensure compliance with Quality Management System requirements for post-market activities, driving NC/CAPA, and PFA processes in partnership with the business.
- Partner with the Professional Services and Technical Support Organization to ensure quality customer outcomes through software solution installation and tech support activities and processes.
- Drive and complete complaint investigations including follow-up with customers and internal cross functional stakeholders while using enterprise tools (SalesForce/SAP/Trackwise/Jira/Windchill/Atlassian Suite/ZenDesk/ServiceNow).
- Conduct risk assessments and Health Hazard Analysis as required in conjunction with R&D and Quality.
- Work on process improvement projects while applying software industry practices, compliance standards and guidance (FDA/HHS).
- Support cybersecurity and data privacy efforts in collaboration with Legal, Compliance, and Product Security teams, addressing monitoring activities and regulatory responses.
- Develop and implement a QMS for non-medical devices to ensure product quality, efficient processes, and compliance with industry standards (e.g., ISO 9001).
Other
- Bachelor’s degree in science or engineering.
- Hybrid role requiring the candidate to be within commuting distance of one of the following locations: San Jose, CA; Orlando, FL; Portage, MI; or Fort Wayne, IN.
- In-office presence required Monday through Wednesday and remote work available on Thursday and Friday.
- Excellent communication, documentation, and cross-functional collaboration skills.
- Depending on customer requirements, employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
