Senior NPI Quality Engineer
Senior NPI Quality Engineer
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Salary Not Disclosed
1 Vacancy
Job Description
Stryker is growing! We are hiring aNew Product Introduction (NPI) Senior Quality EngineerinSalt Lake City Utah to supportNeurovascular! In this role you will collaborate across functions to provide quality assurance support for all aspects of New Product Introductions focusing on longterm strategies for Quality Risk Management Inspection & Testing and Suppliers to ensure product competitiveness and compliance with domestic and international regulations.
What you will do:
Risk Management:
Support the Risk Management File evaluating process risks implementing mitigation strategies and ensuring controls are in place throughout the product lifecycle (from materials to product release) via robust pFMEA.
Ensure compliance with ISO 14971 for all risk management outputs and collaborate on CQA/CTQ identification and dFMEA inputs.
Inspection & Validation:
Support PPAP process validation and test method validation.
Develop and implement lean inspection and validation strategies to ensure scalable compliant and costoptimized processes.
Support First Article Inspections (FAI) develop MSA strategy and promote validation over manual verification.
Process Excellence:
Apply statistical techniques to develop robust predictive quality systems that are transferable and maintainable in production including support for NCs and CAPAs in new products.
Support Design for Manufacture and Assembly (DFMA) through process design inspection optimization and prevention of human factor errors.
Purchase Controls:
Support supplier qualification strategy approve supplier validations and ensure scalable capable processes meet Stryker expectations.
Provide Quality input for supplier selection certification and establishing Quality Agreements for NPI projects.
Design Transfer:
Represent Quality Assurance in the Design Transfer Agreement Plan (DTAP) ensuring launch targets (RFT inspection costs product escapes) are met while providing audit and postlaunch quality support.
What you need
Required:
Bachelor of Science Engineering or related subject.
2 years in Quality Assurance Engineering Design Transfer/Manufacturing Transfer.
Regulated industry experience required.
Preferred:
Experience preferably in the medical device industry.
ASQCQE CQA experience desired.
ISO 13485 and ISO 14971.
Experienced in Validations riskbased and statistical techniques such as FMEA statistical sampling process capability and Measurement System Analysis.
Skilled in using Lean Six Sigma (DMAIC) to solve complex design process and technical issues.
Required Experience:
Senior IC
Employment Type
Full-Time
