JOB OVERVIEW
Assembly Operators are responsible for the assembly of medical components, subassemblies,
products, or systems. Every team member is responsible for maintaining housekeeping and
organization of the work area as well as following CathX Medical policies and procedures. This
role complies to FDA QSR (21 CFR 820), ISO 13485 requirements and adheres to the Quality
Management System (QMS).
ESSENTIAL FUNCTIONS:
? Reads work orders, follows production drawings and sample assemblies, or receives
verbal instructions regarding duties to be performed.
? Ability to perform and demonstrate all Manufacturing procedures after training.
? Accurately complete all essential documents (i.e., Lab Notebooks, Device Master Records
(DMR's), Lot History Records (LHR's), Inspection Records and Validation Documentation).
? Positions and aligns parts in specified relationship to each other in jig, fixture, or other
holding device.
? Crimps, stakes, screws, bolts, rivets, welds, solders, cements, press fits, or perform similar
operations to join or secure parts in place.
? Performs intermediate assembly tasks, such as pad printing, adhesive bonding, hot air
bonding, balloon bonding, etching wires, swaging shafts, fusing skiving shafts, folding,
marking, braiding, coiling, and perform leak testing.
? Adjusts and trims materials from components to achieve specified medical or dimensional
characteristics.
? Performs online go-not-go testing and inspection to ensure parts and assemblies meet
production specifications and standards.
? Packages finished assemblies or subassemblies in clear plastic bags.
? Meeting the daily goals and standards
SUPERVISOR RESPONSIBILITIES:
This position does not have any supervisory responsibilities.
QUALIFICATIONS:
? High School Diploma or equivalent work experience in the medical device industry
? Knowledge of Good Manufacturing Process and Good Documentation Practice
? Ability to read and interpret documents such as safety rules, operating and
maintenance instructions and procedure manuals.
? Must have the ability to calculate figures and amounts using basic math (i.e.
decimals, addition, subtraction, multiplication and division).
? Ability to use measurement tools like microscopes and pin gauges and to
compare measurements to documented standards
Job Posted by ApplicantPro
