Production Operator

Essential Duties And Responsibilities

• Visually inspects, ensures, and assembles parts in process to quality specifications, being aware of critical visual and dimensional defects and determines acceptability of the parts, based on customer specifications.
• Assures accuracy of product packaging and tractability as required, including generating labels, the correct labeling of containers, and accurate part count.
• Operates and maintains production auxiliary equipment utilizing the correct safety precautions.
• Maintains a clean, orderly and safe workstation and environment at all times.
• Communicates with Production leadership regarding any unacceptable parts and any malfunctions of the production process within their workstation.
• Checks part counts by weighing and ensuring that scale(s) are set for accuracy.
• Follows all applicable SOPs, GMPs, and DOIs.
• Contributes to continuous process improvement efforts to reduce scrap, cycle times, improve efficiency, and eliminate waste.
• Supports and contributes in Lean Sigma programs and activities towards delivery of the set target.
• Provides a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.

Basic Qualifications

• Minimum 18 years of age
• Able to read and understand procedures, safety sheets, instructions, and policies in English

Preferred Knowledge, Skills And Abilities

• Experience: 1-3 years of experience, ideally in manufacturing and/or clean room environment
• Education: High School Diploma or GED
• Experience with cGMP practices, ISO, and medical device manufacturing

Physical & Mental Requirements

• Medical Device manufacturing requires strict adherence to standards.
• Working environment is a manufacturing facility, which houses plastic injection molding machines.
• Must tolerate odors, fumes, particulate and loud noises generated from plastics manufacturing and molding processes.
• Must work constructively in an environment that may be stressful due to competing resources while at all times maintaining company confidentiality.
• Must be able to work in a controlled clean room and/or white room environment requiring special gowning.
• Will be required to follow hygiene and gowning requirements and wear protective clothing over the head, face, hands, feet and body.
• Ability to stand and sit for extended periods of time Requires occasional bending at the waist, twisting (at the torso and neck), crouching, climbing, kneeling, balancing, reaching (including overhead), pushing, pulling, grasping, holding and manual dexterity
• Must transport oneself to and from other areas of the facility when necessary
• Ability to understand verbal or written directions, which may include reading English and understanding symbols and warnings
• Must have good visual acuity. If specifically necessitated by customer requirements, must be able to see with or without corrective lenses and distinguish color differences for product and safety issues.
• Must be able to lift a minimum of 25lbs