Quality Assurance Technician

Responsibilities

• Receive and track equipment used by patients or explanted from patients bodies for failure analysis
• Reconcile all received products with quality system records and investigate/resolve any anomalies
• Decontaminate explanted equipment per operating procedures
• Maintain appropriate inventories of decontamination chemicals and process materials
• Perform visual inspection of returned product
• Perform testing of returned product and record findings into the Quality System
• Any and all tasks specified by the Lab Lead/Manager
• Use a microscope 10%-20% of the work day (microscope experience required)
• Perform advanced inspections, review device history records, support nonconformance investigations, and ensure compliance with FDA 21 CFR 820, ISO 13485, and company quality standards

• High school diploma required
• AS or technical degree preferred (engineering, manufacturing, quality)

• Typically 2-4 years in medical device quality or inspection
• Experience with Class II or Class III devices is often preferred
• Strong background in regulated manufacturing environments

“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”