Post Market Quality Engineer (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. The role is hybrid/onsite, focusing on investigations of customer complaints and CAPA management to ensure timely closure and compliance with QSRs.

You will analyze post-market data, partner with R&D, Regulatory Affairs, Field Service, and Sales, and support risk management activities to enhance product safety and performance.

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.

Responsibilities

• Analyze and investigate post-market quality data and trends to identify continuous 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.
• Calculate failure and harm occurrence ratings using field performance data.
• Provide post-market quality input related to product safety, reliability, and design performance.
• Ensure compliance with QSRs, internal procedures, and applicable standards.

Skills

Analytical skills

Problem solving

Communication

Collaboration

Education

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

Job description

## Post Market Quality Engineer (Hybrid)Apply: Redmond, Washington: Full time: Posted Today: R574221Work Flexibility: HybridAs 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 USDView the U.S. work location and transparency guide to find the pay range for your location. Travel Percentage: 10%Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.