Job Description

Position Summary:

• 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 and 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.

Required Qualifications:

• 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

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