Manufacturing Techician

Industry

Manufacturing and Production

Advert ID

USA_485988

Location

Fairfield

Job Type

Contract

Hours

Full-Time

Salary Range

USD16-24 per year

No. of Openings

1

Branch Information

Parsippany, NJ - (USA) 1719 Route 10 Suite 110 NJ Parsippany , NJ 07054

Branch Phone Number

973-539-4115

Job Description

Job Functions: (Primary "essential" duties and responsibilities)



* Set up and maintain production machines and equipment including but not limited to molders, chillers, moisture analyzers, flanging tooling, jigs, ultrasonic welders, printers, Teflon coating machines, etc.

* Assist Engineers with assigned tasks.

* Maintain maintenance logbooks and equipment history records.

* Ensure adequate replacement parts are available for all production equipment.

* Submit requests for Q.E. services for mold (including core pin) qualifications.

* Coordinate machine changeovers for shift/part number changes.

* Ensure resins are dried for the molding machine and molds are inspected and ready for machine changeovers.



Decision-Making Authority:

* Authority to stop manufacturing equipment if the problem would affect quality or conformity to specification.

* Coordinate repairs with Supervisor, Manufacturing Area to assure minimal impact on production schedule.



Required Knowledge, Skills and Abilities:

* Ability to read blueprints. Trouble shooting, maintenance, molding experience. Basic knowledge of electricity, pressure and vacuum systems. Ability to communicate well with fellow workers both verbally and in writing.

* Able to work with minimal direction. Ability to understand process flow charts.



Minimum Requirements:

* High School diploma or equivalent with strong mechanical abilities, with 1-2 years of experience in manufacturing and engineering.

* Basic knowledge of hydraulics, electrical, basic hand tools, and planned maintenance.

* Computer experience in word processing software.



Quality Requirements:

* Build Quality into all aspects of work.

* Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to your job function).

* You must have the education and experience to understand and comply with U.S. and Worldwide medical device regulations (As applicable to your job function).

* Attend all required Quality & Compliance training at the specified interval.

* Adopt the "Beyond Compliance Quality Culture" in the work environment; always meet and exceed requirements.

* Must practice verbatim compliance (exact compliance, no interpretation) with corporate Quality and Regulatory procedures (As applicable to your job function).

* If your job description requires customer facing activities, you must thoroughly understand and comply with the Customer complaint reporting process and complaint procedures (As applicable to your job function).

* Must be able to promptly report any non-compliance issues to Chief QA, RA, Compliance officer or appropriate administrator, including the Compliance Hotline.

* Must be competent with 21 CFR 820, 801, 803, 806 and any other applicable federal regulations, and Quality standards (As applicable to your job function).

* Must not be debarred by FDA for work in any Medical Device or Pharmaceutical business.