Operator - 1st Shift(5:00 AM to 3:30 PM) - Onsite
: Job Details :

Title: Operator - 1st Shift(5:00 AM to 3:30 PM) - Onsite

Description:

This position is responsible for the production of high quality medical devices within a manufacturing cell. Working under close supervision, may perform a combination of assembly, repair, and test operations on pacemakers, implantable cardioverter defibrillators (ICDs), leads, and related medical device assemblies. Performs routine assignments according to specified and/or standardized procedures.

Work is closely and continually reviewed. Ensure that relevant job documentation for cell operations and functions is accurate and up to date.

Be able to clearly communicate ideas, problems and solutions to all levels of manufacturing management in both written and oral form. Maintain a positive attitude when interacting with internal customers and external customers such as tours. Follow safety guidelines and utilize appropriate safety devices when performing all operations. Participate in continuous improvement/quality initiatives in order to enhance production processes to achieve quality and profitability metrics. Maintain accurate records to ensure traveler and quality documents are accurate, all parts are traceable and quality issues can be addressed to assure the quality of all products.

Demonstrates a basis understanding of Lean Manufacturing. Participate with the Manufacturing Supervisor/Manager in setting and monitoring individual goals and cell performance metrics that continuously seek to improve the quality of operations. Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements

Ability to read, comprehend, and follow written procedures; understand and follow verbal instructions - Understanding of and ability to utilize electronic data collection systems and computer software packages.

Ability to prioritize work by determining the sequencing and timing of different jobs based on precedence and importance. Ability to handle and maneuver small components and parts.

Ability to make critical decisions and judgments with minimal supervision. High school degree or equivalent preferred.

Required dress code for tour during interview and on-the job:

Clothing must be non-shedding and free of frayed hems or loose threads. Tassels, fringes, glitter, sequins (sewn or glued on), and any other items that could become dislodges are not allowed on clothing.

To verify a fabric can be worn: pull at the fabric tightly with fingers, if fibers are dislodged, the garment may not be worn in the production area.

Sweaters, sweater vests, loose fiber garments, loose knit, or fleece may not be worn. All clothing must be clean and free of visible contamination (sand, mud, dirt, lint, etc.).

All clothing, from the waist up, must fit under the lab coat/gown. Turtle necks or high-necked clothing shall not stick out above the neck of the lab coat/gown.

Sleeves shall not stick out beyond the cuff of the lab coat/gown. Caps, hats, scarves or bandanas shall not be worn under the bouffant.

Head wraps/scarves worn to accommodate customs: Must be covered with the bouffant and the tail end of the scarf must be fully covered by the lab coat/gown.

Must be of tightly woven fabric, be clean, and laundered. Loose fitting clothing shall not be worn around machinery or soldering/brazing torches. Shoes must be worn at all times in the production area.

Stockings or socks are required. The heel of a shoe must not be pointed or higher than 2 inches. Sandals, clogs, slippers, open toe, or open heel shoes are not allowed.

Shoes with straps or weave where toes can be seen are not allowed. Changing shoes in the production area, other than a gowning room, is not allowed.

Torsos, upper arms, and legs must be covered. Pants (above the ankle), skirts (above the ankle), skirts with slits, short shirts (above the navel), and sleeveless tops are not allowed.

Skirts at the ankle are allowed, but full-length stockings, leggings, or pants must be worn under them. Nail polish, acrylic, artificial nails, or similar nail coatings are not allowed.

Jewelry or body piercings that can pierce gloves or cannot be covered under gowning materials will not be allowed in the production area.

Makeup shall not be worn. Lip balm in stick form is acceptable, when applied outside of production areas and prior to hand washing.

Scented personal use products shall not be worn, except deodorant. Lotions shall not be applied after hand washing. Cover any open or bleeding wound with a bandage. Don't wear anything that could be offensive.

Job Will Entail: Building Medical Devices Product through Assembly; Inspecting, Testing, Periodic Microscope work - not continuous, some Packaging and Boxing; there will be Cross-Training

Will Need to Gown-up, use Hair Net, Beard Net, Shoe Covers, Safety Glasses

Requires the operating of electrical Torch drivers & Screw Drivers

Experience Required: 1 to 3 years of experience in Clean-Room working with Medical Devices in

Medical Device Industry only; must have some form of Assembly experience in MD; Must be able to Speak, Read, and Write English; preferably understand SOPs in FDA and GMP

Education:

H.S. Diploma or GED - Minimum

Note :

Hours: 5:00 AM to 3:30 PM

4 - 10 hour days on Monday through Thursday

Location: 100% Onsite