Senior Manager, Quality Systems - Design Controls Global Process Owner

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.
• What you will do
• + •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.
• What you will need
• Required
• + 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.

• Preferred
• + 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).

Posted Date:

05/04/2026 This role will be posted for a minimum of 3 days. $135,600 - $293,700 USD Annual View the U.S. work location and transparency guide (https://view.stryker.com/viewer/fcd609f31e39eac44598615224ec7216?iid=69deda99678eb495e0710914#1) to find the pay range for your location.

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.