Hybrid Post-Market Quality Engineer: Drive CAPA

Regulatory Jobs; Redmond (WA); Hybrid; USD 80,000 - 128,000; Full time

Job summary

Stryker Corporation in Redmond, WA is seeking a Post Market Quality Engineer to drive post-market quality improvements, investigate customer complaints, and own NC/CAPA actions in a hybrid work setting. Apply rigorous root cause analysis, partner with R&D, Regulatory Affairs, Field Service, and Sales, and ensure compliance with QSRs and ISO standards to safeguard product quality and patient safety.

The role emphasizes data analysis, risk management, and cross-functional communication in a

Qualifications

• Bachelor's degree in Engineering, Science, or a related technical discipline.
• 0-2 years of professional experience.
• Strong analytical and problem-solving skills.
• Excellent communication and collaboration skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Demonstrated ability to learn quickly and drive results.

Responsibilities

• Analyze and present post-market quality data including complaints and trends to identify improvement opportunities.
• Investigate customer complaints and drive records to timely closure.
• Own and support NC and CAPA investigations.
• Partner with cross-functional teams (R&D, Regulatory Affairs, Field Service, Sales) to resolve issues.
• Conduct and maintain risk analyses and support Risk Management activities.
• Provide post-market quality input related to product safety and design performance.
• Ensure compliance with QSRs, procedures, and quality standards.
• Communicate product quality insights to stakeholders.

Skills

Analytical skills

Problem solving

Communication

Collaboration

Education

Bachelor's degree in Engineering/Science

Job description

Stryker Corporation in Redmond, WA is seeking a Post Market Quality Engineer to drive post-market quality improvements, investigate customer complaints, and own NC/CAPA actions in a hybrid work setting. Apply rigorous root cause analysis, partner with R&D, Regulatory Affairs, Field Service, and Sales, and ensure compliance with QSRs and ISO standards to safeguard product quality and patient safety.

The role emphasizes data analysis, risk management, and cross-functional communication in a