Senior Quality Systems Lead – CAPA & Compliance (Hybrid)

Stryker; Redmond (WA); Hybrid; USD 83,000 - 139,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Stryker in Redmond, WA is seeking a Senior Quality Systems Specialist to drive the quality management system, lead CAPA and NC processes, and partner with cross-functional teams to resolve issues and ensure regulatory compliance in a hybrid work setting.

The role requires a Bachelor's in Science or Engineering and 3+ years in manufacturing, with strong communication and project management skills, experience with CAPA, quality systems, and audits. Some travel may be required.

Qualifications

• Bachelor's degree in Science, Engineering, or a related field.
• Minimum 3+ years of experience in a manufacturing environment or equivalent.
• Strong communication, project management, and influencing skills.

Responsibilities

• Own and oversee NC and CAPA processes to ensure compliance, effectiveness, and efficiency.
• Review and approve NCs and CAPAs for completeness and timeliness.
• Partner with cross-functional teams to facilitate investigations and root-cause analyses.
• Serve as site SME and super user for the eCAPA system with proper records.
• Coach teams on problem-solving methods (5 Whys, Fishbone, Process Mapping, 4-D).
• Lead CAPA review boards and RCA workshops to drive quality improvements.
• Monitor and report NC/CAPA KPIs for governance forums.
• Develop and deliver training programs on CAPA processes and quality systems.
• Identify and implement continuous improvement initiatives to optimize quality systems.
• Participate in cross-site and corporate quality improvement projects.
• Support audits with preparation, participation, and follow-up.

Skills

Quality systems

CAPA

Project management

Cross-functional collaboration

Education

Bachelor's degree in Science or Engineering

Tools

eCAPA system

MS Office

Job description

Stryker in Redmond, WA is seeking a Senior Quality Systems Specialist to drive the quality management system, lead CAPA and NC processes, and partner with cross-functional teams to resolve issues and ensure regulatory compliance in a hybrid work setting.

The role requires a Bachelor's in Science or Engineering and 3+ years in manufacturing, with strong communication and project management skills, experience with CAPA, quality systems, and audits. Some travel may be required.