Post Market Quality Engineer (Hybrid)
Stryker
Post Market Quality Engineer (Hybrid)
Stryker
Posted 5 days ago
Full Time
Redmond, Washington
Hybrid
Smart Summary
Responsibilities
The Post Market Quality Engineer will investigate customer complaints, manage nonconformance and CAPA processes, and identify product quality trends. They will also collaborate with cross-functional teams to conduct risk analyses and ensure compliance with quality standards.
Qualifications
You have a Bachelor's degree in Engineering, Science, or a related technical discipline with 0-2 years of professional experience. You possess strong analytical and problem-solving skills, excellent communication and collaboration abilities, and can manage multiple priorities in a fast-paced environment.
Must Have Skills for ATS
Root Cause Analysis
8D
ISO 13485
ISO 14971
FDA Quality System Regulations
Six Sigma
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 Annual
View 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.
Stryker
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