Senior Quality Engineer
Senior Quality Engineer
Posted on :
19-04-2025
Employer Active
1 Vacancy
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Job Description
Work Flexibility: Onsite
What you will do
- Continuously comply with all regulatory related requirements. Will conduct Internal and External audits. May train others in Quality Assurance/GMP/FDAQSR 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 nonconforming 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 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 inhouse and supplier quality problems using established problemsolving 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 onsite at Strykers 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.
Required Experience:
Senior IC
Employment Type
Full-Time
Key Skills
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