Post-Market Quality Engineer - CAPA, RCAs & Risk Trends

Stryker; Redmond; Hybrid; AUD 114,000 - 181,000; Full time

Benefits offered by this job

Health benefits

401(k) plan

Employee Stock Purchase Plan (ESPP)

Wellbeing program

Job summary

Stryker in Redmond, WA seeks a Post Market Quality Engineer to drive post-market quality improvements. You will analyze complaints, lead CAPA/NC investigations, and work with R&D, Regulatory Affairs, Field Service and Sales to resolve issues.

Responsibilities include risk analyses, data trending, and ensuring compliance with QSRs and ISO standards. The role is hybrid/onsite, requiring strong analytical, communication, and cross-functional collaboration skills.

Qualifications

• Bachelor's degree in Engineering, Science, or related technical discipline.
• 0-2 years of professional experience.
• Strong analytical and problem-solving skills.
• Excellent communication and collaboration skills.

Responsibilities

• Analyze and present post-market quality data including complaints, service reports, Q-metrics, and trending to identify continuous improvement opportunities.
• Investigate customer complaints and drive records to timely closure.
• Own and support Nonconformance (NC) and Corrective and Preventive Action (CAPA) investigations.
• Partner with customers and cross-functional teams including R&D, Regulatory Affairs, Field Service, and Sales to resolve product quality issues.
• Conduct and maintain risk analyses, document findings, and support Risk Management activities.
• Calculate failure and harm occurrence ratings using field performance data.
• Provide post-market quality input related to product safety, reliability, durability, and design performance.
• Ensure compliance with Quality System Regulations (QSRs), internal procedures, and applicable quality standards.
• Communicate product quality insights and trends to internal and external stakeholders.

Skills

Analytical skills

Problem solving

Communication

Education

Bachelor's degree in Engineering/Science

Job description

Stryker in Redmond, WA seeks a Post Market Quality Engineer to drive post-market quality improvements. You will analyze complaints, lead CAPA/NC investigations, and work with R&D, Regulatory Affairs, Field Service and Sales to resolve issues.

Responsibilities include risk analyses, data trending, and ensuring compliance with QSRs and ISO standards. The role is hybrid/onsite, requiring strong analytical, communication, and cross-functional collaboration skills.