Join Stryker as a **Senior Quality Assurance Engineer** in **Redmond, WA** supporting Emergency Care! (https://www.stryker.com/us/en/emergency-care.html) In this role, you will help ensure that life-saving medical devices meet the highest standards of quality and safety, while driving 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:**
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 manufacturing processes across operations and key business functions.
+ **Lead** internal and supplier nonconformance investigations, including problem definition, containment, root cause analysis, and timely closure against agreed due dates.
+ **Manage** and prioritize multiple quality initiatives simultaneously, balancing competing priorities across cross-functional partners.
+ **Own** corrective and preventive actions (CAPA), including documentation, effectiveness checks, and on-time completion through closure.
+ **Review** and **approve** change control activities to support compliant implementation and sustained process performance.
+ **Analyze** key performance indicator trends (e.g., defects, scrap, yield) and drive improvement actions to reduce waste and variation.
+ **Support** process and equipment validation/qualification activities, including protocol review, execution support, and report approval.
+ **Prepare** audit evidence and support internal/external audits, including response development and follow-up actions within committed timelines.
+ **Apply** risk management and human factors considerations to manufacturing operations, including risk assessments and mitigation planning.
**What you will need**
**Required**
+ Bachelor's degree in Science, Engineering, or a related discipline.
+ Minimum 2 years of experience in quality, manufacturing, or engineering; experience in regulated industries is a plus but not required.
**Preferred**
+ Knowledge of medical device manufacturing and quality system standards (e.g., ISO 13485, Good Manufacturing Practice).
+ Lean Six Sigma training or certification.
+ Experience with nonconformance management, CAPA, change control, and audit support.
+ Experience applying risk management tools and statistical methods (e.g., sampling plans, process capability, measurement system analysis, Gauge R&R).
+ Familiarity with regulatory bodies (e.g., FDA, notified bodies, Ministry of Health) and compliance expectations.
**US15** : $89,400 - $148,900 USD Annual
View the U.S. work location and transparency guide (https://view.stryker.com/viewer/fcd609f31e39eac44598615224ec7216?iid=69deda99678eb495e0710914#1) to find the pay range for your location.
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, Orthopaedics and Spine 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.
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.