Job : Mechanical Inspector/ Tester
Location : MA
Onsite
DESIRED SKILLSET:
1.High School Diploma or equivalent
2.2+ yrs. in a similar quality inspection role
3.Prior medical device experience a plus
4.Knowledge of FDA Quality System requirements and ISO 13485 requirements a plus
5.Excellent organizational, verbal, written communication, and problem-solving skills.
6.Possess above-average interpersonal skills demonstrating the ability to work with others in a professional, positive, and collaborative manner.
7.Ability to work in a fast-paced environment and to meet tight deadlines.
8.Willingness to learn, possess a can-do attitude, and motivated to succeed and grow.
9.Ability to multi-task with strong attention to detail
10.Proficient in MS Office Suite, and of Statistical Process Control Practices
ESSENTIAL FUNCTIONS / MAJOR RESPONSIBILITIES:
1.Perform incoming mechanical inspection on a variety of medical devices including custom needle assemblies, stainless steel surgical instruments, scalpel blades, glass LOR syringes, trocars, etc.
2.Interpret engineering drawings and blueprints to determine inspection points and required product specifications.
3.Use a variety of instruments for visual, dimensional, functional, and destructive testing (micrometer, caliper, video measuring equipment, Lloyd materials tester, pin gages, etc.)
4.Conduct a variety of functional testing i.e. (pull, peel, burst, penetration)
5.Generate Certificates of Conformance for accepted material prior to release of product
6.Perform final inspection on packaged material ready to be shipped by confirming shipping documentation and product labeling.
7.Release material from Pending QA Inspection location to packaging area once the material has been inspected, accepted, and a COC has been generated.
DESIRED SKILLSET:
1.High School Diploma or equivalent
2.2+ yrs. in a similar quality inspection role
3.Prior medical device experience a plus
4.Knowledge of FDA Quality System requirements and ISO 13485 requirements a plus
Process Control Practice