Manager Software Post-market Quality

Work Flexibility: Hybrid or Onsite

Stryker is hiring a Manager Software Postmarket Quality to manage a team of post market Quality Assurance engineers that work on Software as a Medical Device (SiMD) or Software in a Medical Device (SiMD) for our Digital Health solutions for our medical division for postmarket projects. This team collaborates with Professional Services Technical Support and PostMarket Quality teams to address customer complaints manage product field actions oversee customer communications and support release management ensuring a strong customer quality framework.

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 Portage MI Kalamazoo MI or Fort Wayne IN. The work schedule is structured to support flexibility with inoffice 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 and develop a team of postmarket quality engineers focused on customer quality initiatives for Software in a Medical Device (SiMD) Software as a Medical Device (SaMD) and medical devices within Stryker Medicals Digital Health portfolio

• Drive product quality and compliance partnering with Professional Service Post Market Technical Support and Research & Development (R&D) to prioritize projects allocate resources and provide customer excellence.

• Oversee postmarket process improvements ensuring compliance in software development verification & validation risk management NonConformance and Corrective Action and Preventative Action (NC/CAPA) risk management and product security activities.

• Manage and execute risk management activities Software Failure Effects Analysis (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 datadriven 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 KPIs as necessary.

What you need:

Required Qualifications:

• Bachelors degree in engineering

• Minimum of 8 years of experience working within the medical device or Medical Technology industries.

• Minimum of 1 year of experience leading teams within a highly regulated industry in following cGMP and GDP regulations.

• Experience in postmarket quality in overseeing NonConformances and Corrective Action and Preventative Action (NC/CAPA) managing product field actions and handling customer complaints through systems such as Trackwise SAP Salesforce or Zendesk.

Preferred Qualifications:

• Experience with 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.

115600.00 to 245800.00 salary plus bonus eligible benefits. Actual minimum and maximum may vary based on 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 contractors legal duty to furnish information.