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Senior Quality Engineer, New Product Introduction

$89.4k - $148.9k

Stryker

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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