Quality Engineer (Hybrid)

Stryker•Plainfield, IN

7d•Hybrid

About The Position

Stryker is hiring a Quality Engineer for our Global Logistics and Operations division. This is a hybrid position based in Plainfield, IN. As the Quality Engineer, you will join a collaborative quality and manufacturing team focused on ensuring product and process compliance within a regulated environment. This role supports day-to-day quality assurance activities, drives issue resolution, and contributes to continuous improvement initiatives across manufacturing operations. You will work cross-functionally to maintain product quality, support audits, and ensure adherence to established standards.

Requirements

Bachelor’s degree in Science, Engineering or related technical field
Minimum 0–2 years of experience in quality, regulatory, or engineering role
Familiarity with quality standards such as ISO 13485, Good Manufacturing Practices, or Good Documentation Practices
Experience using Microsoft Office tools (Word, Excel, PowerPoint)

Nice To Haves

Experience in a regulated industry such as medical devices or manufacturing
Knowledge of quality principles including risk management, corrective and preventive actions, audits, and statistical analysis
Experience supporting validation activities or quality management systems

Responsibilities

Partner with operations and cross-functional teams to monitor product and process quality performance and address gaps.
Own and manage non-conformances, ensuring timely investigation, root cause identification, and closure.
Support and execute corrective and preventive actions, tracking progress through to completion.
Disposition non-conforming product and document quality actions within defined systems and processes.
Collaborate with suppliers on quality issues, including escalating corrective action requests and monitoring resolution timelines.
Analyze quality data and KPIs to identify trends, implement improvements, and maintain process control.
Support internal and external audits by providing documentation, data, and subject matter input.
Apply statistical methods and quality tools to evaluate manufacturing processes and support validation activities.