Overview
Senior QA Lead Jobs in Denver, CO at Etana Custody
Essential Duties & Responsibilities
Perform accurate mechanical, physical and visual inspections of raw materials, components, and sub-assemblies as per inspection plans and specification requirements
Perform PCI activities for NA Notifications at the US Regional Service Center as needed.
Follows all procedural requirements in the area of responsibility in order to maintain compliance to applicable Quality System Regulations (i.e cGMP compliance).
Supports the paper document archival process including preparation of pallets for shipment to R4 as well as the scanning of Documents for electronic archival in Agile.
Initiate Non-Conformance reports as required
Supports NC and CAPA activities as needed
Work on special projects as they may arise
Knowledge, Skills & Qualifications
Minimum HS graduate or GED equivalent. AA or Technical Degree preferred.
Must have basic computer skills to regularly access and document information in a computer.
Must have basic written and oral communication skills adequate to communicate with other team members, understand verbal instructions, and read and comprehend written work instructions including words and engineering drawings.
Demonstrated knowledge with medical device regulations and FDA regulatory standards preferred.
Education and Experience
High School Diploma is required
Minimum Qualifications
Must be at least 18 years of age
Travel Requirements
Typically requires travel less than 5% of the time
Physical Requirements and Work Environment
Must be able to perform essential job functions in an office environment.
Long periods of sitting to enter/ analyze data is expected
Must have adequate manual dexterity to operate standard office equipment
Must be able to occasionally lift objects up to 25 lbs.
Title: Senior QA Lead
Company: Etana Custody
Location: Denver, CO
