Senior Manager, Quality Operations (Onsite)

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

Job summary

Stryker is hiring a Senior Manager, Quality Operations for the Emergency Care division. This onsite leadership role will drive quality system execution, investigations, CAPA, and performance metrics to uphold patient safety and regulatory compliance.

You will partner across Quality, R&D, Manufacturing, Supply Chain, and Finance to standardize processes, lead audits, and develop teams through coaching and succession planning, while aligning with business objectives and budgets.

Qualifications

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

Responsibilities

• Lead day-to-day quality system activities, investigations, CAPA, and timely resolution of issues.
• Establish and monitor quality performance metrics, KPIs, and reporting.
• Manage product quality, safety, complaints, and corrective action processes with regulatory alignment.
• Develop and implement quality process improvements and standardization initiatives.
• Partner with QA, R&D, Manufacturing, Supply Chain, Commercial, and Finance teams.
• Represent quality during audits and ensure readiness and effective follow-up.
• Develop budgets, forecasts, resource plans, and departmental objectives.
• Recruit, develop, coach, and manage team members with succession planning.

Skills

Leadership

Quality management

Regulatory compliance

Cross-functional collaboration

Process improvement

Education

Bachelor's degree in Engineering/Life Sciences/Quality/Manufacturing

Master's degree

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.

What You Need

Required

• 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