Senior Software Quality Engineer, Post Market

Stryker • San Jose, CA • 15h ago

Stryker is hiring a Senior Software Quality Engineer, Post Market to support our Medical's Digital Health division and portfolio Software as a Medical Device (SaMD)/Software in a Medical Device (SiMD) to support projects as a quality engineer for post-market activities to drive customer quality.

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; Orlando, FL; Portage, 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.

What you will do:

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).

Act as a subject matter expert on all related procedures, ensuring compliance to the relevant procedures.

Work on cybersecurity monitoring and data privacy related responses with Legal/Compliance/Product Security teams.

Oversee and track post-market KPIs for MDR, business reviews, and continuous process improvement, providing data analytics, KPI insights, and project status updates in business and management reviews.

What you need:

Required:

Bachelor's degree in science or engineering.

Minimum of 2 years of experience.

Preferred:

Experience working in the areas of Research & Development (R&D), Quality (QA/QC), Information Technology, Healthcare IT, Regulatory Affairs (RA) or Technology industry.

Previous employment at leading technology companies such as Amazon, Google, Microsoft, or similar, demonstrating strong technical skills.

Experience with Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD), supporting post-market activities to ensure compliance, drive customer quality, and address regulatory requirements, with proficiency in Salesforce, SAP, TrackWise, Jira, Windchill, Atlassian Suite, Zendesk, and ServiceNow.

Experience in software technical support resolution, ensuring compliance with industry standards in handling Non-Conformances and Corrective Action and Preventative Action (NC/CAPA). Additionally, extensive experience within themedical device industry, ensuring compliance with regulatory standards such asFDA 21 CFR Part 820, ISO 13485, and IEC 62304, including handling Non-Conformances and Corrective Action and Preventative Action (NC/CAPA).

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. 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.

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.

Stryker

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