Staff Software Quality Engineer, Post Market

Stryker; San Jose (CA); Hybrid; USD 87,000 - 187,000; Full time

Job summary

A leading company in medical devices is seeking a Staff Software Quality Engineer to enhance post-market quality and compliance efforts. This hybrid role involves collaborating on quality management processes, conducting risk assessments, and driving customer outcomes through effective software solutions. Candidates should possess a Bachelor's degree in engineering and relevant experience in quality assurance within regulated environments.

Qualifications

• Minimum 4 years in R&D, Quality, or related fields.
• Experience in handling NC/CAPA processes in medical devices.
• Proficiency in relevant software tools for compliance.

Responsibilities

• Ensure compliance with Quality Management System for post-market activities.
• Drive complaint investigations and collaborate with technical support.
• Conduct risk assessments and oversee post-market KPIs.

Skills

Software technical support

Quality compliance

Risk assessment

Education

Bachelor's degree in science or engineering

Tools

Salesforce

SAP

TrackWise

Jira

Windchill

Atlassian Suite

Zendesk

ServiceNow

Job description

Work Flexibility: Hybrid or Onsite

Stryker is hiring a Staff 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 4 years of experience working in the areas of Research & Development (R&D), Quality (QA/QC), Regulatory Affairs (RA), Information Technology (IT), Healthcare IT, Consumer Electronics or Technology industries.

• Experience in software technical support resolution in handling Non-Conformances and Corrective Action and Preventative Action (NC/CAPA).

Preferred:

• 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 software Failure Modes Effect Analysis (sFMEA), Security Risk Assessments and defect management, software testing and/or verification/validation.

• 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.

87,600.00 to 186,700.00 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.

Travel Percentage: 20% 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 Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.