Quality Engineer
Quality Engineer
Posted on :
03-07-2025
Employer Active
1 Vacancy
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Job Description
Job Description:
As a Quality Engineer for New Product Introduction (NPI) at Stryker you will provide technical leadership for quality assurance and control activities throughout the product lifecycle. You will lead initiatives related to risk management (pFMEA) process validation supplier qualification and inspection strategy design ensuring regulatory compliance and successful product launches.
Responsibilities:
As a Quality Engineer for New Product Introduction (NPI) at Stryker you will provide technical leadership for quality assurance and control activities throughout the product lifecycle. You will lead initiatives related to risk management (pFMEA) process validation supplier qualification and inspection strategy design ensuring regulatory compliance and successful product launches.
Responsibilities:
- Support new product design and transfer with strong cross-functional collaboration.
- Develop and optimize inspection strategies using lean methods.
- Lead or support CAPAs validations (IQ/OQ/PQ) risk analysis and PFMEA.
- Coordinate with suppliers to ensure quality in materials and documentation (e.g. PPAP).
- Maintain and review design history files (DHF) and risk management documentation per ISO 14971.
- Serve as a Quality lead during Design Transfer Agreement Planning (DTAP)
Represent QA in regulatory audits.
- Bachelors in engineering or related field.
- 3 5 years in a quality engineering or related technical role
- Experience with ISO standards PFMEA NPI Design Transfer Risk Management and Validation.
- Knowledge in CQA CTQ ISO 14971 MSA and manufacturing process controls.
- Strong production documentation overhaul experience (e.g. MVPs value stream mapping).
- Hands-on with medical device validation and design control.
Employment Type
Full Time
Key Skills
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