Location: Pittsfield,MA, USA
JOB PURPOSE: 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 logs - Assists / Trains operators on part visual acceptability, and measurement and process procedures as required - Document quality opportunities / findings through a Non-conforming Report. - Perform review of Device Master Record - Assure quality programs are designed to achieve customer specification and continually evaluates quality assurance and/or control methods - Assure 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 followed - Ensure that all equipment safeties are not altered or defeated. QUALIFICATIONS (Education/Experience/Knowledge, Skills & Abilities) - Associate Degree or equivalent, or 2-3 years\' related experience and/or training, or equivalent combination of education and experience in inspection in the medical industry - Strong Computer skills; Microsoft Office (Word, Excel) and Minitab - Knowledge 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 details - Leadership skills and team player - Highly organized - Ability to work with a high volume of documents in a fast-paced environment and multitask - Strong written, verbal, time management and interpersonal skills - Mechanical aptitude desired - Experience with programming and operation of Coordinate Measuring Machines (CMM), inspection of machine components, and performance of gage R&R studies preferred - Must be able to lift up to 50 lbs. - Must have good vision - Must have manual dexterity - Must be able to sit or stand for long periods of time - Repetitive motions are required - Requires frequent bending, squatting, and twisting motions - Must be able to climb stepladders - Must be able to climb up and down stairs - Must be available for overtime as needed - Environment: Noise level is uncontrolled (Ear plugs are provided.) - Travel is required to support company initiatives - Perform job duties in accordance to ISO 13485/9001 including ISO audits