Hybrid Senior Manager, Quality Systems – Design Controls

at Stryker

• Job title: Senior Manager, Quality Systems – Design Controls
• Job type: Full Time
• Experience level: Senior
• Salary: $135,600 - $293,700 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Kalamazoo, United States

About the role

• Senior Manager leading company-wide Design Controls processes for medical devices. Responsible for regulatory compliance and process improvement across global operations.

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.

Requirements

• 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).