Senior Manager, Quality Systems - Design Controls Global Process Owner

Stryker • Kalamazoo, IN

12d • Hybrid

About The Position

As the Senior Manager, Quality Systems – Design Controls Global Process Owner (GPO), this role is responsible for setting the direction for Stryker’s company-wide Design Controls practices and processes in alignment with applicable medical device regulatory requirements. You will lead the architecture, planning, management, and implementation of global processes, documentation, and systems that support our Quality Management System across divisions and locations. This role operates in a global environment with frequent collaboration including across EMEA. Candidates based in Eastern Time hours are strongly preferred.

Requirements

• Bachelor’s degree in Engineering, Computer Science, Software Engineering, Life Sciences, or a related technical discipline.
• Minimum 10 years of experience in medical device design and development within a regulated environment.
• Minimum 5 years of technical leadership supporting design engineering and/or design controls.
• Direct experience with medical device regulatory requirements.
• Experience designing, governing, or implementing quality system processes for regulated medical devices.
• Experience authoring and maintaining technical documentation in a regulated compliance environment.

Nice To Haves

• Electrical or software engineering degree is a plus.
• Master’s degree in engineering or engineering management.
• Experience leading multi-divisional design programs/projects across organizations and geographies.
• Experience with information systems supporting regulated development (e.g., electronic document management systems, technology management, software validation).

Responsibilities

• Lead the design and implementation of company-wide Design Controls processes (including packaging) and related enabling processes/technologies.
• Apply an end‑to‑end understanding of the product development lifecycle to guide design control strategy from design planning through verification, validation, and design transfer.
• Establish governance and boundaries for harmonization and alignment by partnering with Corporate, Division, Global Quality, Engineering leaders, and key business partners.
• Develop input and content for Design Controls within the Global Quality Manual and Quality Management System planning activities.
• Define and drive requirements to assess Design Controls process effectiveness, including packaging, and manage continuous improvement actions.
• Analyze and report process performance metrics to demonstrate ongoing effectiveness and support related quality/engineering functions.
• Serve as the Design Controls process expert for acquisition integrations and post-integration remediation actions.
• Act as a primary point of contact for Corporate Office regulatory and health authority inspections related to Design Controls.
• Coach and guide Division Process Owners and hub-and-spoke teams to implement, maintain, and improve global processes, documents, and systems; resolve or escalate effectiveness/efficiency issues through leadership.

Benefits

• 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/V/D.
• 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.
• Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better.
• We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.
• We are proud to be named one of the World’s Best Workplaces!

What This Job Offers

• Job Type: Full-time
• Career Level: Senior