Staff Quality Engineer
Stryker
Stryker is hiring a **Staff** **Quality Engineer, in San Jose, CA** to support **Endoscopy –** Sports Medicine! (https://www.stryker.com/us/en/sports-medicine.html) In this role, you’ll drive impactful quality improvements to address top customer issues. If you are someone who enjoys interfacing with customers and the clinical setting, this role will enable you to partner with clinicians, sales reps, and marketing to identify opportunities and deliver solutions. Additionally, you’ll get to collaborate across functions to analyze, evaluate, and implement changes to our products, and you will work in the highly dynamic and fast-growing Sports Medicine market segment.
**What you will do:**
+ **Cross-Functional Collaboration** : Partner with clinicians, sales reps, design engineering, manufacturing, suppliers, regulatory, and marketing teams to identify, communicate, and resolve quality issues.
+ **Root Cause & Risk Analysis** : Conduct root cause investigations using statistical and quality tools; assess customer risk and determine acceptability of non-conforming materials.
+ **Product & Process Improvement** : Support 2–5 products or product families through continuous improvement initiatives, including root cause analysis of unit and system failures, detailed defect analysis using statistical methods, and development and execution of corrective action plans.
+ **Testing & Validation** : Support design verification (benchtop) testing, including development of clinically relevant test methods, statistical analysis of results, and evaluation of any failures or deviations. Participate in design validation testing in human cadavers working with users (e.g. surgeons)
+ **Quality System Support** : Maintain QMS documentation, support audits, and develop subject matter expertise with potential process ownership.
+ **Reporting & Metrics** : Prepare reports, monitor quality metrics, and communicate performance trends to stakeholders.
+ **Mentorship** : Provide guidance and mentorship to junior engineers.
**What you need:**
**Required:**
+ Bachelor’s degree required: in engineering, scientific or related discipline preferred.
+ 4+ years’ related experience within a regulated industry.
**Preferred:**
+ Medical device experience preferred.
+ Comfortable in surgical and cadaveric settings.
+ Adaptable and comfortable in dynamic, fast-paced environments.
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.
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