Senior Engineer, Quality Assurance

Stryker

. Lead product field action assessments from initiation through review and approval .

Posted 10/30/2026full-timeUnited StatesSenior💰 $77,700 - $129,500 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in quality assurance processes, including conducting post-market health risk assessments and managing nonconformance records. Proficient in structured problem-solving and root cause analysis within regulated industries such as medical devices.

Highest-signal resume keywords

Quality AssurancePost-Market Quality AssessmentsRoot Cause AnalysisISO 13485Six Sigma Green Belt

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Structured Problem-SolvingHealth Hazard EvaluationsCorrective ActionsStatistical Evaluation MethodsDocumentation ManagementRisk AssessmentsContainment RecommendationsNonconformance RecordsAction Owner DefinitionDeliverable Coordination

Soft Skills

CollaborationCommunicationLeadership

Certifications & Qualifications

Six Sigma Green Belt

Industry Keywords

Regulated IndustryMedical DevicesAerospaceISO 1497121 CFR Part 820European Union Medical Device Regulation

About the role

Key responsibilities & impact

Lead product field action assessments from initiation through review and approval
Ensure complete, accurate, and timely documentation
Investigate complex product quality issues using structured problem-solving, root cause analysis, and statistical evaluation methods
Perform post-market health risk assessments and health hazard evaluations
Develop containment recommendations and corrective actions based on investigation findings, risk assessments, and quality data
Author and manage nonconformance and corrective and preventive action records
Define deliverables, action owners, timelines, and supporting documentation
Coordinate investigation and corrective action reviews with Research & Development, Manufacturing, Regulatory, Quality, Marketing, Service, and supplier teams
Represent Quality Assurance processes during internal and external audits
Maintain compliance with applicable quality system, risk management, and post-market requirements

Requirements

What you’ll need

Bachelor’s degree in science, engineering, or a related discipline
Minimum 2 years of experience in quality assurance or customer quality
Experience working in a regulated industry, such as medical devices or aerospace
Experience conducting post-market quality assessments
Candidates must reside within a commutable distance to Redmond, WA or Portage, MI
Able to work onsite several times per week
Preferred: Master’s degree in science, engineering, or related discipline
Preferred: Experience conducting product field actions
Preferred: Experience working with ISO 14971, ISO 13485, 21 CFR Part 820, and European Union Medical Device Regulation requirements
Preferred: Six Sigma Green Belt certification or experience with formal investigative techniques

Benefits

Comp & perks

Hybrid work flexibility
Equal opportunity employment
Pay transparency and pay discussion protections