Post-Market Quality Engineer - Remote/Hybrid

Stryker Corporation; Redmond (WA); Hybrid; USD 80,000 - 128,000; Full time

Job summary

Stryker Corporation in Redmond, Washington is seeking a Post Market Quality Engineer to drive continuous product and process quality improvements.

You will investigate customer complaints, own NC/CAPA investigations, and collaborate with cross-functional teams including R&D, Regulatory Affairs, and Field Service to resolve quality issues while ensuring compliance with QSRs and ISO standards.

Qualifications

• Bachelor's degree in Engineering, Science, or related technical discipline.
• 0-2 years of professional experience.
• Knowledge of complaint handling, post-market surveillance, CAPA, and nonconformance processes.
• Experience with failure investigation methodologies including Root Cause Analysis, 8D, or similar tools.
• Familiarity with statistical analysis techniques and data trending.
• Knowledge of ISO 13485, ISO 14971, and FDA Quality System Regulations.

Responsibilities

• Analyze and present post-market quality data including complaints, service reports, Q-metrics, and trending to identify improvement opportunities.
• Investigate customer complaints and drive records to timely closure.
• Own and support NC and CAPA investigations.
• Partner with customers and cross-functional teams to resolve product quality issues.
• Conduct risk analyses, document findings, and support Risk Management activities.
• Provide post-market quality input related to product safety, reliability, durability, and design performance.
• Ensure compliance with QSRs, internal procedures, and applicable quality standards.

Skills

Analytical thinking

Problem solving

Communication skills

Cross-functional collaboration

Project management

Regulated industry experience

Root Cause Analysis

8D problem solving

Statistical analysis

Education

Bachelor's degree in Engineering, Science, or related technical discipline

Job description

Stryker Corporation in Redmond, Washington is seeking a Post Market Quality Engineer to drive continuous product and process quality improvements.

You will investigate customer complaints, own NC/CAPA investigations, and collaborate with cross-functional teams including R&D, Regulatory Affairs, and Field Service to resolve quality issues while ensuring compliance with QSRs and ISO standards.