Hybrid Quality Systems Lead: CAPA & Compliance

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

Job summary

Stryker Corporation in Redmond, WA is seeking a Senior Quality Systems Specialist to drive NC and CAPA processes within a hybrid work model. You will lead investigations, perform root cause analysis, and ensure timely CAPA execution across cross-functional teams.

The role requires a Bachelor’s in Science or Engineering, 3+ years in manufacturing, strong analytical and regulatory know-how, and the ability to coach teams in problem-solving. Travel may be required.

Qualifications

• Bachelor’s degree in Science, Engineering, or a related discipline.
• Minimum 3+ years of experience in a manufacturing environment or equivalent.
• Strong analytical, critical thinking, and problem-solving capabilities.
• Experience interacting with regulatory agencies such as FDA, TUV, and other international regulatory bodies.
• Knowledge of U.S., European, and international medical device regulations and standards.
• Willingness to travel as needed.

Responsibilities

• Own and oversee the NC and CAPA processes to ensure compliance, effectiveness, and efficiency in addressing quality issues.
• Review and approve NCs and CAPAs for completeness, accuracy, effectiveness, and timeliness.
• Partner with cross-functional teams to facilitate investigations, root cause analysis, and corrective action implementation.
• Serve as the site subject matter expert and super user for the eCAPA system, ensuring records are maintained with appropriate supporting evidence.
• Coach and mentor teams on problem-solving methodologies, including 5 Whys, Fishbone Diagrams, Process Mapping, Human Error Reduction, and 4-D methodologies.
• Lead accountability meetings, CAPA review boards, and root cause analysis workshops to drive quality improvements.
• Monitor and report NC/CAPA key performance indicators (KPIs), providing updates for quality and business review forums.
• Develop, maintain, and deliver training programs related to CAPA processes and quality systems.
• Identify and implement continuous improvement initiatives to optimize quality systems and business processes.
• Participate in cross-site and corporate quality system improvement projects.
• Support internal, corporate, customer, and third-party audits, including preparation, participation, and follow-up activities.

Skills

Strong communication

Project management

Influencing skills

Independent work

Education

Bachelor’s degree in Science/Engineering

Tools

Microsoft Office

Job description

Stryker Corporation in Redmond, WA is seeking a Senior Quality Systems Specialist to drive NC and CAPA processes within a hybrid work model. You will lead investigations, perform root cause analysis, and ensure timely CAPA execution across cross-functional teams.

The role requires a Bachelor’s in Science or Engineering, 3+ years in manufacturing, strong analytical and regulatory know-how, and the ability to coach teams in problem-solving. Travel may be required.