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Job description
Senior Quality Assurance Engineer
Join Stryker and help ensure that life-saving medical devices meet the highest standards of quality and safety. In this role, you’ll drive initiatives that enhance product performance and compliance, directly impacting patient outcomes worldwide. If you’re passionate about quality and continuous improvement, this is your opportunity to make a difference.
Work Flexibility:
Hybrid: Candidates must reside within a commutable distance to Redmond, WA and be able to work onsite 4 days per week.
What You Will Do
- Ensure quality performance of products and processes across operations and business functions.
- Manage internal and supplier-driven non-conformances, ensuring timely investigation and closure.
- Own corrective and preventive actions (CAPAs) through root cause analysis and resolution.
- Review and approve change management activities, driving effective implementation and continuous improvement.
- Analyze KPI trends and lead initiatives to optimize manufacturing processes and reduce waste.
- Support process and equipment validation, qualification, and measurement system analysis (MSA).
- Provide quality assurance support during internal and external audits to maintain compliance.
- Advocate for human factor practices and apply risk management principles to manufacturing operations.
What You Will Need
Required Qualifications
- Bachelor’s degree in Science, Engineering, or related discipline (Electrical, Mechanical, Industrial, or Biomedical preferred).
- 2+ years of experience in quality, manufacturing, and/or engineering.
Preferred Qualifications
- Knowledge of medical device manufacturing processes, ISO 13485, and GMP standards.
- Lean Six Sigma training or certification.
- Experience with risk management, CAPA, audits, and statistical techniques.
- Familiarity with regulatory agencies (FDA, MoH, TUV) and compliance requirements.
- High level knowledge/experience of Risk Based and statistical techniques, in particular process risk, statistical sampling plans, Process Capability, Gauge R&Rs.
$88,800.00 - $142,300.00 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
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