CAPA & Quality Systems Lead - Hybrid (Redmond)

Stryker; Redmond; Hybrid; AUD 119,000 - 198,000; Full time

Benefits offered by this job

Hybrid work model

Health benefits

Job summary

Stryker in Redmond, WA is seeking a Senior Quality Systems Specialist to drive CAPA/NC processes, partner with cross-functional teams, and serve as the site expert for the eCAPA system. This role emphasizes quality excellence, regulatory compliance, and continuous improvement across the organization.

The position requires a Bachelor’s degree in Science or Engineering and 3+ years in manufacturing or similar settings, with strong communication and project management skills.

Qualifications

• Bachelor’s degree in Science, Engineering, or related discipline required.
• 3+ years of experience in manufacturing or equivalent.
• Strong communication, project management, and influencing skills.

Responsibilities

• Own and oversee the Nonconformance (NC) and Corrective and Preventive Action (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

Cross-functional collaboration

Analytical thinking

Problem-solving

Education

Bachelor’s degree in Science/Engineering or related

Tools

Microsoft Office

Job description

Stryker in Redmond, WA is seeking a Senior Quality Systems Specialist to drive CAPA/NC processes, partner with cross-functional teams, and serve as the site expert for the eCAPA system. This role emphasizes quality excellence, regulatory compliance, and continuous improvement across the organization.

The position requires a Bachelor’s degree in Science or Engineering and 3+ years in manufacturing or similar settings, with strong communication and project management skills.