Quality Engineer
$92,000–$146,000 year
On-site · Lockbourne, Ohio, United States
Job Summary
Quality Engineer responsible for qualifying Philips Hospital Patient Monitoring parts, ensuring quality assurance systems, conducting supplier quality audits, CAPA, data analysis, and maintaining compliance with FDA-regulated medical device requirements and ISO standards. Roles include reviewing/approving quality records and documentation, sustaining quality metrics, implementing and standardizing quality processes across sites, performing routine inspections and audits, and driving continuous improvement and risk management within manufacturing and warehousing environments. The role emphasizes nonconformance management, CAPA, root-cause analysis, and data-driven decision making to support product quality and customer satisfaction.
Required Qualifications
- Minimum 3+ years’ experience in FDA regulated Medical Device manufacturing/warehousing quality environments (ISO 13485) with focus on parts qualification, quality audits/inspections, nonconformance management, control plans, QMS compliance/standardization, and continuous/process improvement
- Bachelor's Degree in an Engineering or quality discipline
- Six Sigma/DfX (DFx/DFR) knowledge and/or certifications desired
Additional Requirements
- US work authorization is a precondition of employment; company will not sponsor work-authorized visa now or in the future
- Relocation benefits not provided
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