Quality Engineer in Belfast at Stryker Corporation

Date Posted: 9/25/2018

Job Snapshot

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Job Description

Investigate customer complaints to determine product failure root causes and evaluate risk of failures.
Investigate related failures, design, and manufacturing history of failed devices.
Document complaint and failure investigation results as appropriate.
Maintain risk documentation as appropriate.
Trend and Analyze post market product failure data and provide updates to Division quality leadership.
Support pre-BIC design controls activities utilizing post market product data.
Participate in cross-functional product improvement teams to identify and define product improvement opportunities.
Initiate, track, and document product hold issues initiated by the Division.
Author and/or contribute to Technical Assessments and other information to be used in the Product Field Action process.
Support the International registration process for new and existing products.
May travel as needed to customer accounts to provide product expertise and observe utilization practices.
May assist the service repair team with troubleshooting returned devices.
May conduct internal Quality system audits and be involved with CAPA projects.
May assist Product Engineering in a quality engineering support role, to include:
Helping guide R&D through the quality system to ensure product changes are carried out in compliance to those procedures as well as the requirements of the FDA, ISO, and other regulatory bodies.
Reviewing and evaluating product change documentation for compliance as well as sound technical competence to ensure delivery of robust products changes.
Performing risk analysis and developing mitigation strategies for product changes.
Collaborating to develop robust verification test strategies to ensure safe, reliable product changes are implemented

Work From Home: No

Travel Percentage: None

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