Senior Manager, Quality Operations (Onsite)

Stryker; Redmond (WA); On-site; USD 156,000 - 260,000; Full time

Benefits offered by this job

Health benefits

401(k) and ESPP

Life insurance

Job summary

Stryker in Redmond, WA is seeking a Senior Manager, Quality Operations for the Emergency Care division. This onsite role leads quality process execution, investigations, and continuous improvement with a cross‑functional team.

You will manage quality systems, regulatory compliance, and performance metrics, partnering with QA, R&D, Manufacturing, Supply Chain, and Commercial groups to ensure patient safety and product quality across the organization.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Quality, Manufacturing, or related discipline.
• Minimum 10 years in Quality, Quality Systems, Manufacturing Quality, Regulatory Affairs, or related regulated industry function.
• Minimum 4 years of people leadership experience with performance management and development responsibilities.
• Experience in FDA/ISO/governed regulated environments.
• Experience managing quality systems, investigations, CAPA, or product quality programs.

Responsibilities

• Lead day-to-day quality system activities, ensuring investigations and CAPAs are evaluated and resolved.
• Establish and monitor quality performance metrics and reporting processes.
• Manage product quality, safety, complaints, and CAPA processes for regulatory compliance.
• Develop and implement quality process improvements and standardization initiatives.
• Partner with QA, R&D, Manufacturing, Supply Chain, Commercial, and Finance teams to support quality objectives.
• Represent quality during audits and ensure audit readiness and follow-up actions.
• Develop budgets, forecasts, and departmental objectives.
• Recruit and coach team members and support succession planning.

Skills

Quality leadership

Quality systems

Regulatory compliance

Cross-functional collaboration

Budgeting

Education

Bachelor's degree or equivalent in related field

Master's degree in related field

Tools

SAP

Oracle

JD Edwards

Job description

Stryker is hiring a Senior Manager, Quality Operations for our Emergency Care division. This is an onsite role based in Redmond, Washington.

As the Senior Manager, Quality Operations, you will lead the team responsible for quality process execution, issue resolution, performance monitoring, and continuous improvement initiatives. You will partner across functions to ensure quality systems remain effective, compliant, and aligned with business objectives while supporting product quality and patient safety.

This position is responsible for leading quality systems and process excellence activities, managing quality performance across the organization, supporting regulatory compliance, and developing teams that ensure consistent execution of quality processes and continuous improvement initiatives.

What You Will Do

• Lead day-to-day quality system activities, ensuring quality issues, investigations, and corrective actions are evaluated, documented, and resolved in a timely manner.
• Establish and monitor quality performance metrics, key performance indicators, and reporting processes to identify trends and drive continuous improvement.
• Manage product quality, safety, complaint, and corrective action processes, ensuring compliance with applicable regulatory and quality requirements.
• Develop and implement quality process improvements, standardization initiatives, and operational strategies to improve efficiency and consistency across the organization.
• Partner with Quality Assurance, Research & Development, Manufacturing, Supply Chain, Commercial, and Finance teams to support business and quality objectives.
• Represent quality systems and processes during internal, external, regulatory, and third-party audits, ensuring audit readiness and effective follow-up actions.
• Develop annual budgets, forecasts, resource plans, and departmental objectives to support organizational priorities.
• Recruit, develop, coach, and manage team members, establishing performance goals and supporting employee development and succession planning.

Required

What You Need

• Bachelor’s degree in Engineering, Life Sciences, Quality, Manufacturing, or a related discipline.
• Minimum 10 years of experience in Quality, Quality Systems, Manufacturing Quality, Regulatory Affairs, or a related regulated industry function.
• Minimum 4 years of people leadership experience, including performance management and employee development responsibilities.
• Experience working within a regulated environment governed by FDA, ISO, or other international quality and regulatory requirements.
• Experience managing quality systems, complaint investigations, corrective and preventive action processes, or product quality programs.

Preferred

• Master’s degree in Engineering, Science, Quality, Business, or a related field.
• Experience applying Lean, Six Sigma, or other continuous improvement methodologies.
• Experience with enterprise resource planning systems, including SAP, Oracle, or JD Edwards.
• US15: $155,900 - $259,800 USD Annual

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.