Senior Engineer, Quality Assurance Engineering
The Judge Group
Our client is currently seeking a Senior Engineer, Quality Assurance Engineering for a 6 month + contract.
Medical, dental, and vision insurance are available to qualified candidates who meet eligibility requirements.Job Description :As a Divisional Quality Engineer, you will play a critical role in strengthening product reliability across the lifecycle, from post-market insights to product improvements that shape future innovations. This role offers meaningful impact, cross-functional collaboration, and the opportunity to influence products used by healthcare professionals worldwide. What You Will Do:
•Investigate product failures by reviewing design history, manufacturing records, and field performance data to identify root causes and improvement opportunities.
• Analyze and trend post-market product complaint data, delivering regular, data-driven insights to divisional quality leadership.
• Update risk management documentation to reflect post-market findings and product changes, ensuring continued product safety and effectiveness.
• Participate in cross-functional product improvement teams to define, prioritize, and execute corrective and preventive actions.
• Initiate, track, and document commercial product holds, ensuring timely resolution and accurate records. Support business units and commercial teams by providing post-market quality expertise and technical guidance.
• Facilitate and coordinate subject matter experts to develop technical documentation for product field action assessments and present findings to governance boards and senior leadership.
• Guide research and development teams through quality system requirements to ensure product changes comply with regulatory and quality standards, including reviewing change documentation for technical robustness. TOP 3 skills :
- Good communication skills (2+ years)
- Documentation and print review (2+ years)
- Quality investigation experience (2+ years) Top 3 Nice to haves :
- NC/CAPA experience, even better if it's in TrackWise (1+ years)
- Print and document review experience (1+ years)
- Data trending experience Med device or pharma preferred EDUCATION : Bachelor's Degree in Engineering (any discipline) required
Vacancy posted 8 hours ago
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