Stryker ยท 9 hours ago
Senior Engineer, Quality Assurance
Redmond, WA
Full-time
Hybrid
Mid, Senior Level
$89K/yr - $142K/yr
2+ years expStryker is a company that offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics, and Spine to improve patient and healthcare outcomes. As a Senior Quality Assurance Engineer, you will lead investigations and drive improvements to ensure quality excellence across the product lifecycle.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
Lead product field action assessments (PFAA) from initiation through board approval, ensuring timely and thorough execution
Investigate customer complaints and non-conformances, determine root causes, and assess health risks to support regulatory compliance
Conduct health risk assessments (HRA) and document findings in Trackwise to support post-market surveillance
Author and manage non-conformance (NC) and corrective/preventive action (CAPA) records, collaborating with cross-functional teams to define deliverables and timelines
Provide statistical analysis and containment recommendations to support quality investigations and decision-making
Serve as a subject matter expert in risk management, product safety, and quality assurance processes, mentoring peers and supporting audits
Partner with regulatory teams to ensure accurate and timely reporting to competent authorities
Drive continuous improvement by strengthening interfaces between pre-market and post-market processes and promoting cohesive risk management strategies
Qualification
Required
Bachelor's degree in science, engineering, or a related discipline
2+ years of experience in quality assurance or customer quality
Demonstrated experience with ISO 14971, ISO 13485, CFR 21 Part 820, and EUMDR
Experience conducting post-market quality assessments and product field actions
Preferred
Master's degree in a related field
Certified Quality Engineer (CQE) or Certified Reliability Engineer (CRE)
Six Sigma Green Belt or Black Belt certification
Experience in a regulated industry (e.g., Medical Device, Aerospace)
Benefits
Medical and prescription drug insurance
Dental insurance
Vision insurance
Critical illness insurance
Accident insurance
Hospital indemnity insurance
Personalized healthcare support
Wellbeing program
Tobacco cessation program
Health Savings Account (HSA)
Flexible Spending Accounts (FSAs)
401(k) plan
Employee Stock Purchase Plan (ESPP)
Basic life and AD&D insurance
Short-term disability insurance
Company
Stryker
Stryker is a medical technology company that offers products and services in orthopaedics.
10001+ employees
H1B Sponsorship
Stryker has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (82)
2024 (76)
2023 (63)
2022 (78)
2021 (57)
2020 (77)
Funding
Current Stage
Public CompanyTotal Funding
unknown1990-01-02IPO
Leadership Team
Kevin Lobo
Chief Executive Officer
Glenn S. Boehnlein
Chief Financial Officer and Vice President
Recent News
GlobeNewswire News Room
2025-02-11
Company data provided by crunchbase