Post Market Quality Engineer

Stryker

. Analyze and present post-market quality data including complaints, service reports, Q-metrics, and trending to identify continuous improvement opportunities .

Posted 9/29/2026full-timeRedmond • Washington • United StatesJuniorMid-Level💰 $79,900 - $127,500 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates strong analytical skills and problem-solving capabilities while effectively communicating product quality insights. Familiar with regulatory compliance and risk management processes in the medical device or pharmaceutical industries.

Highest-signal resume keywords

Post-Market SurveillanceCorrective And Preventive Action (CAPA)Root Cause AnalysisQuality System Regulations (QSRs)Statistical Analysis Techniques

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Data AnalysisFailure Investigation MethodologiesRisk ManagementQuality Improvement InitiativesComplaint Handling

Soft Skills

Analytical SkillsProblem-Solving SkillsCommunication SkillsCollaboration SkillsTime Management

Industry Keywords

ISO 13485ISO 14971Medical DevicePharmaceuticalsAerospace

About the role

Key responsibilities & impact

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

Requirements

What you’ll 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
Preferred: Knowledge of complaint handling, post-market surveillance, CAPA, and nonconformance processes
Preferred: Experience with failure investigation methodologies including Root Cause Analysis, 8D, or similar problem-solving tools
Preferred: Familiarity with statistical analysis techniques and data trending
Preferred: Knowledge of ISO 13485, ISO 14971, and FDA Quality System Regulations
Preferred: Experience developing and implementing design controls and process controls
Preferred: Experience supporting risk management and product quality improvement initiatives

Benefits

Comp & perks

Hybrid work flexibility
10% travel percentage