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Arroyo, PR, 00714, US
Job details
Work flexibility: Onsite
Req ID: R536507
Employee type: Full Time
Job category: Engineering
Travel: 10%
Relocation: No
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Why join Stryker?
Looking for a place that values your unique talents? Discover Stryker's award-winning culture.
We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.
Job description
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.