Senior Quality Engineer
Stryker
**What you will do –**
+ Continuously comply with all regulatory related requirements. Will conduct Internal and External audits. May train others in Quality Assurance/GMP/FDA-QSR related topics.
+ Design and/or implement methods and procedures for inspecting, testing, and evaluating the precision and reliability of products and/or production and/or test equipment: Statistical process control, Incoming part/product inspection criteria, Automated testing, Functional gauging, Productivity improvements
+ Stop further processing in the event of encountering non-conforming products condition. May design and/or specify inspection and testing mechanisms and equipment. Prepare documentation for inspection/testing procedures.
+ May support vendor management issues: Problem solving, Auditing, Inspection techniques/equipment, Training. May interact with suppliers either telephonically or in person to develop and standardize inspection methods and or techniques to ensure components compliance with specifications.
+ May interact with customers either telephonically or in person to solve reliability issues and/or answer general product questions. Complaint investigation/problem solving, Customer training, Design improvements and Special Orders.
+ May assist during new product development. Validation support for product, processes, packaging, software, and sterilization. Analyze reports and/or returned products and recommends corrective action. Will conduct failure analysis of products and processes: Problem solving efforts, Reliability design improvements, Product failure trending, Training.
+ Work closely with Operations to resolve in-house and supplier quality problems using established problem-solving methodologies (Root Cause Analysis, Mistake Proofing, etc). Lead and participate in the development and improvement of the manufacturing processes for existing and new product. Review and approve inspection plans, routers and product drawings.
+ Lead in development, review and approval of process and equipment validation/qualifications.
**What you will need –**
+ Work every day on-site at Stryker’s manufacturing plant in Arroyo.
+ B.S. in engineering or engineering related discipline required.
+ Experience in Quality Assurance Engineering or related functional area required.
+ At least Intermediate English skills required.
+ Experience in Quality Assurance training desired.
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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