Summary: Seeking a Medical Device Quality Assurance Engineer to support nonconformance investigations, supplier issues, and product development activities.

Requirements:

3-5 years of manufacturing quality experience in the medical device industry Extensive knowledge of 21 CFR 820 and ISO 13485 Strong proficiency in Microsoft Word and Excel Experience with electro-mechanical assembly, ESD controls, cabling, clean room processes, labeling, sterilization

Preferred Skills:

Knowledge of advanced statistical methods and software tools like Minitab Experience in process validation and test method validation/Gage R&R activities Prior start-up experience

Responsibilities:

Support material nonconformance investigation and disposition activity Assist with maintenance of calibration system Support creation and maintenance of DHRs, routers, bills of material for manufacturing Perform incoming inspection review for product components Document activities in compliance with medical standards and regulations Assist in quality issue investigations from product complaints, CAPAs, non-conforming reports

Pay Details: $95,000.00 to $110,000.00 per year

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
The California Fair Chance ActLos Angeles City Fair Chance OrdinanceLos Angeles County Fair Chance Ordinance for EmployersSan Francisco Fair Chance Ordinance