QA Technician III

Overview

Major responsibilities include receiving and tracking equipment used by patients or explanted from patients’ bodies for failure analysis; reconciling all received products with quality system records and investigating/resolving any anomalies; decontaminating explanted equipment per operating procedures; maintaining appropriate inventories of decontamination chemicals and process materials; performing visual inspection of returned product; performing testing of returned product and recording findings into the Quality System;

and completing any and all tasks specified by the Lab Lead/Manager. The job requires microscope experience. Around 10% to 20% of the work day will be spent using a microscope. The role includes performing advanced inspections, reviewing device history records, supporting nonconformance investigations, and ensuring compliance with FDA 21 CFR 820, ISO 13485, and company quality standards.

• 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 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.
• Carry out any and all tasks specified by the Lab Lead/Manager.
• The job requires microscope experience; around 10% to 20% of the work day will be spent using a microscope.
• Responsible for performing advanced inspections, reviewing device history records, supporting nonconformance investigations, and ensuring 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.