Post Market Quality Engineer (Hybrid)

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

Job summary

Stryker Group in Redmond, WA is seeking a Post Market Quality Engineer responsible for driving continuous product and process quality improvements. You will analyze post-market data, investigate complaints, and own NC/CAPA investigations while collaborating with R&D, Regulatory, Field Service, and Sales to resolve issues.

The role emphasizes risk analyses, applying QSRs and ISO standards, and ensuring product safety and reliability.

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 to identify improvement opportunities.
• Investigate customer complaints and close records timely.
• Own and support NC and CAPA investigations.
• Collaborate with R&D, Regulatory, Field Service, and Sales to resolve issues.
• Conduct risk analyses and support Risk Management activities.
• Calculate failure and harm occurrence ratings using field data.
• Provide post-market input on product safety and reliability.
• Ensure compliance with QSRs and quality standards.
• Communicate product quality insights to stakeholders.

Skills

Analytical

Problem solving

Communication

Collaboration

Multi-tasking

Education

Bachelor's degree in Engineering/Science

Tools

Root Cause Analysis

Job description

As a Post Market Quality Engineer, you will be responsible for continuous product and process quality improvements. You will conduct investigations into Customer Complaints, identify emerging trends, dictate action plans, and eventually own NC/CAPAs. You will support root cause activities and identify potential failure modes, risks, and resolve customer issues appropriately.

This role is Hybrid/Onsite in Redmond, Washington.

What You Will Do

• 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.

What You Need

• 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 and work effectively in a fast-paced environment.
• Demonstrated ability to learn quickly, navigate complexity, and drive results.

Preferred

• Experience working in a regulated industry such as Medical Device, Pharmaceuticals, Aerospace, or Manufacturing.
• Knowledge of complaint handling, post-market surveillance, CAPA, and nonconformance processes.
• Experience with failure investigation methodologies including Root Cause Analysis, 8D, or similar problem-solving tools.
• Familiarity with statistical analysis techniques and data trending.
• Knowledge of ISO 13485, ISO 14971, and FDA Quality System Regulations.
• Experience developing and implementing design controls and process controls.
• Experience supporting risk management and product quality improvement initiatives.

United States of America Pay Ranges:

• US15: $79,900 - $127,500 USD

View the U.S. work location and transparency guide to find the pay range for your location.