Set up and operation of diverse types of equipment used to manufacture various types of medical instruments/implants within established JIT manufacturing processes, GMP's, and quality requirements.
Duties & Other Responsibilities:
Sets up and operates diverse types of machinery within secondary manufacturing operations. Performs assigned tasks, in order to produce, inspect and package various types of medical products. Equipment used depends on product being manufactured or operation being performed. Operator will inspect finished and in-process product for dimensional and cosmetic attributes according to defined specifications. Operator will also assemble, package, and label various orthopedic medical devices following specific procedures, and operate various manual and semi-automatic packaging equipment.
All of these operations are inspected using diverse types of measuring equipment including, but not limited to: micrometers, calipers, dial indicators, depth gages, thread gages, angle gages, bore depth gages, hex gages, plug gages, ball height gages, comparators, calibrated standards, optical / computerized gauging and inspection microscopes.
Ensures that in process quality checks are completed following established quality specifications. Interface with quality and other production employees to resolve problems.
Ensures production requirements are met, product quality is maintained, machine maintenance schedule is adhered to, area cleaning is completed and all workplace safety rules are complied with at all times.
Works in accordance with all requirements for manufacturing medical devices (e.g. FDA QSR, ISO 9000, ISO 13485).
Completes required documentation as required by process, and inspection sheets and work instructions.
Must be present during scheduled manufacturing cell operation.
Provides support by filling in for absences in qualified areas within manufacturing cell.
Will interface with maintenance, tool room, quality, materials, and other manufacturing employees, as needed.
Other duties as assigned.
Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.
Professional Experience & Educational Requirements :
Education and training normally associated with a high school diploma.
Must understand metric dimensional specifications and have good basic math and reading skills.
Demonstrate proficiency in the use of diverse measurement instruments including those noted above.
Basic computer skills are desirable.
Possess good written and verbal communication skills.
Ability to learn and adhere to specific procedures according to the department training plan.
Duties assigned may vary to suit business needs.
Must be able to demonstrate proficiency on all equipment within the secondary operations in order to be considered for the Sr. level position.
Must be in the job 1 year to be considered for the Sr. level position.
Synthes - 19 months ago
Brittle, broken, battered bones cease to be a problem with Synthes around. The company makes devices, instruments, and implants used for the...