Quality Assurance Engineer Design Control

Job Description

• The Quality Assurance Specialist -Design Control will provide advanced-level, hands-on support from a regulated systems perspective in a GxP laboratory services and kitting production environment • Key position for any individual who enjoys working in a cross-functional environment • Activities include supporting the maintenance of Design History File, compiling Risk Management, and reviewing KPIs to assure effectiveness of the QMS

Qualifications

• Bachelor’s Degree or equivalent combination of education and experience • 4 years of related experience in a life science, regulated environment • In-depth knowledge and hands-on experience with products designed and commercialized under ISO 13485, ISO14971, and 21CFR Part 820 standards • Experience with IVDR, ISO15189, CAP/CLIA

Benefits

• Reasonable estimate of the current range • $75,000 - $110,000 USD