Stryker is hiring a Senior Staff Quality Systems Engineer to support our Medical’s Digital Health division and portfolio (Software as a Medical Device/Telehealth) to be responsible for defining and maintaining the quality management systems, processes, continuous improvement projects, project management and regulatory compliance for our digital health business.
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. Relocation assistance is approved for eligible candidates.
What you will do:
Manage projects to establish direction for digital health business Quality Management Systems (QMS) and processes, enabling compliance and alignment with industry standards (IEC 62304/ISO 9001).
Collaborate with functional leaders (R&D, IT, Product Security, Regulatory, Privacy, Legal) to drive strategic decisions for the digital health business.
Develop and execute quality plans in partnership with business unit leaders, aiming to deliver measurable results.
Generate analytics reports and perform data analysis to support quality plans, including trending insights for decision-making.
Lead continuous improvement initiatives for QMS and business processes, tracking progress with defined KPIs.
Facilitate enterprise system support (e.g., Salesforce, SAP, Jira) to enable digital health operations in coordination with corporate and business units.
Partner with regulatory affairs to maintain compliance with standards across digital health, cybersecurity, and consumer regulations (FDA, HIPAA).
Present analytics, KPIs, and project updates to senior leadership and support global compliance audits (FDA, ISO, SOC II, Hitrust) while managing non-conformances and CAPAs.
What you need:
Required:
Bachelor’s degree in science or an engineering discipline.
Min 6+ years working in a regulated industry – preferable in medical device – (R&D, Quality or RA)
Demonstrated knowledge and experience working through software lifecycle processes (Agile SAFe/Waterfall).
Preferred:
Demonstrated experience in the Medical Device and Technology Industry managing quality management systems.
Knowledge of software technologies for mobile, cloud and AI/ML solutions. (Amazon AWS/Microsoft Azure/Apple/Android etc.) preferred.
112,800.00 to 239,900.00 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: 10%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.