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Together with our customers, we're on a mission to make healthcare better.
The Role
Lead cross-functional quality investigations, drive corrective actions (CAPA), contain nonconforming product, analyze quality data and trends, support audits, and ensure compliance with QMS and applicable regulatory standards (21 CFR 820, ISO 13485, MDSAP).
Summary Generated by Built In
Work Flexibility: OnsiteWhat you will do:The Quality Engineer will collaborate cross-functionally to resolve quality issues, drive continuous improvement, and ensure adherence to the Quality Management System and regulatory standards.Beyond quality, your efforts contribute to the organization's compliance with an array of other pertinent regulatory requirements that pertain to our industry and the markets we serve. This regulatory adherence is pivotal in maintaining our reputation, fostering customer trust, and ensuring market access.
- Escalate quality issues to QA and/or Engineering Management and support timely resolution.
- •Partner cross-functionally with Engineering, Production, and other teams to ensure quality standards are consistently met.
- •Lead and participate in investigations of non-conformances, including risk assessments and corrective action strategies (CAPA).
- •Ensure proper containment of non-conforming product (identification, segregation, and reconciliation).
- •Monitor, analyze, and trend quality data to identify potential risks and provide insights to management.
- •Ensure compliance with the Quality Management System and applicable regulatory requirements.
- •Support internal and external audit activities and address audit observations.
- •Apply statistical and risk management tools (e.g., FMEA) to support decision-making and continuous improvement.
Top Skills
21 Cfr 820
Capa
Fmea
Iso 13485
Mdsap
Quality Management System
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The Company
What We Do
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at www.stryker.com.
Together with our customers, we are driven to make healthcare better.
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