Senior Quality Engineer, New Product Introduction
$89.4k - $148.9kStryker
Senior Quality Engineer supporting new medical device product introductions and manufacturing process transfers at Stryker. The role encompasses risk management, process validation, supplier quality, and design transfer activities in a regulated manufacturing environment.
Responsibilities
- Execute and document quality engineering activities for new product and process introductions
- Develop inspection strategies, sampling plans, and measurement system analysis approaches
- Support process validation protocols, sterilization validation, and design reviews
- Apply statistical methods to evaluate process capability and investigate nonconformances
- Execute supplier qualification, validation, and production part approval activities
Requirements
- Bachelor's degree in Engineering or related technical discipline
- Minimum 2 years quality, engineering, or technical experience
- Experience in regulated manufacturing environment
- Knowledge of risk management and process controls
- Medical device manufacturing and ISO 13485 familiarity (preferred)
- Certified Quality Engineer (CQE) certification or equivalent (preferred)
- Lean Six Sigma training and statistical quality tools experience (preferred)
Compensation: $89,400 - $148,900 USD Annual
Vacancy posted 1 day ago
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