Lumicity ยท 4 days ago
Sustaining Quality Engineer
Irvine, CA
Contract
Onsite
Mid Level
$55/hr - $70/hrLumicity is a company that specializes in the medical device industry, and they are seeking a Sustaining Quality Engineer to lead engineering activities for Class II medical devices. The role involves ensuring ongoing product quality through process controls, validations, and cross-functional coordination for investigations and changes.
Human ResourcesRecruitingStaffing Agency
Hiring Manager
James Kilburn
Responsibilities
Lead sustaining engineering activities for Class II medical devices, including process controls, validations, and in-process inspection strategies to ensure ongoing product quality
Drive CAPA, NCMR, and failure investigations; coordinate cross-functional teams to assess and implement component, product, and process changes
Support equipment qualification, process validation, test method validation, and ISO 14971 risk management activities in partnership with Operations and Supplier Quality
Qualification
Required
BS in Engineering or related field
Strong knowledge of ISO 13485, ISO 14971, and 21 CFR 820, including design, purchasing, risk, and process controls
Proven experience leading CAPA investigations and supplier corrective actions
Preferred
ASQ CQE preferred
Company
Lumicity
Lumicity is a technical staffing agency that provides staffing solutions for engineering, life sciences, technology, and energy industries.
Founded in 2016
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase