At-a-Glance:
Are you ready to build your career by joining a certified technology solutions and compliance consulting services company. If so, our client is hiring a Product Quality Engineer.
Position Type:
Required:
Bachelor’s degree in Engineering (Mechanical, Electrical, Biomedical preferred). 5+ years of experience in product quality, complaint investigation, or root cause analysis in an FDA-regulated industry. Working knowledge of FDA Quality System Regulations, ISO 13485, EU MDR, ISO 14970, GMP, GDP, and Design Control requirements. Strong expertise in root cause analysis tools and ability to lead investigations for complaints, NCs, and CAPAs. Excellent communication, presentation, and cross-functional team collaboration skills. Experience with risk-based decision-making, statistical analysis, test method validation, and verification/validation requirements for regulated products. Ability to work independently, manage complex investigations, and travel to customer sites (<25%); familiar with controlled environments and safety considerations.
Responsibilities:
- Lead complaint investigations, root cause analyses, and risk assessments for on-market medical devices.
- Prioritize complaints and investigations based on product risk, data analysis, and strategic impact.
- Partner with cross-functional teams to determine CAPA needs, implement improvements, and communicate root cause findings.
- Conduct Health Risk Assessments (HRA) and evaluate on-market products for impact and required corrective actions.
- Perform data analysis and trending of complaint and failure mode data; prepare and present findings to internal stakeholders.
- Lead projects for design or process changes, including updates to drawings, fixtures, tooling, testing, and change control documentation.
- Support audits and inspections, including internal, supplier, Notified Body, and FDA inspections, and present quality metrics to leadership.
Get in Touch:
We want to hear from you! If you think you'd be a good match, submit your resume and reach out to Ashish at (201) 210-5320 to learn more.
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