Staff Quality Engineer (Onsite)
Core
Support Quality Assurance activities in a regulated medical device environment by monitoring product/process quality, investigating nonconformances, and ensuring compliance with FDA and ISO standards.
Role type
Staff Quality Engineer
Builds
Quality management systems and compliant medical device products
Domain
Medical Devices / Regulated Manufacturing
Required skills
Risk assessment, CAPA management, statistical sampling, FMEA interpretation, audit support, data trend analysis, nonconformance investigation
Preferred skills
Medical device industry experience, CAPA/nonconformance management, FMEA, risk management, statistical sampling, quality audits
Technologies
Microsoft Word, Microsoft Excel
Responsibilities
Investigate product and process quality issues; coordinate containment and disposition of nonconforming product; monitor and trend quality data; manage Corrective and Preventive Action (CAPA) activities; apply statistical methods for sampling plans; interpret risk management documentation (FMEA); support internal and external audits; partner with cross-functional teams to resolve quality issues.
Seniority
Staff, hands-on IC