Job Description:
- Able to perform entry level inspection, repetitive tasks associated with visual inspections and basic functional testing knowledge. Responsible for ensuring company products are in compliance with internal and external specifications by performing a variety of routine and non routine inspections and evaluations.
- Ability to perform inspection tasks use microscopes, calipers, and micrometers.
- Able to complete 10-15 different inspection.
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.
