Location: Pittsfield,MA, USA
Responsible for the visual and dimensional inspection of all products according to the customer requirements. Responsible for creating and maintaining measurement programs and inspection records.ESSENTIAL DUTIES:Perform dimensional and visual inspection (dimensions such as length, height, contamination and distance) using precision instruments such as micrometers, calipers, dial indicator, Micro Vu and CMM to ensure product meets specifications.Documents inspection results by completing reports and logsAssists / Trains operators on part visual acceptability, and measurement and process procedures as requiredDocument quality opportunities / findings through a Non-conforming Report.Perform review of Device Master RecordAssure quality programs are designed to achieve customer specification and continually evaluates quality assurance and/or control methodsAssure products are manufactured in compliance with regulatory requirements and manufacturing plans are monitored for compliance to ISO, GMP standards.Ensure that all safety procedures are followedEnsure that all equipment safeties are not altered or defeated.QualificationsAssociate Degree or equivalent, or 2-3 years' related experience and/or training, or equivalent combination of education and experience in inspection in the medical industryStrong Computer skills; Microsoft Office (Word, Excel) and MinitabKnowledge of GD&T print interpretation (reading drawings/blueprints)Need to know how to use hand tools (caliper, micrometers, pin gages, scales, drop gages, etc.)Must have a strong attention to detailsLeadership skills and team playerHighly organizedAbility to work with a high volume of documents in a fast-paced environment and multitaskStrong written, verbal, time management and interpersonal skillsMechanical aptitude desiredExperience with programming and operation of Coordinate Measuring Machines (CMM), inspection of machine components, and performance of gage R&R studies preferredMust be able to lift up to 50 lbs.Must have good visionMust have manual dexterityMust be able to sit or stand for long periods of timeRepetitive motions are requiredRequires frequent bending, squatting, and twisting motionsMust be able to climb stepladdersMust be able to climb up and down stairsMust be available for overtime as neededEnvironment: Noise level is uncontrolled (Ear plugs are provided.)Travel is required to support company initiativesPerform job duties in accordance to ISO 13485/9001 including ISO audits