Each shift is a 12-hour shift, with a rotating schedule (commonly referred to as a 2-2-3-2 schedule):
- Nights - 5:45pm - 6:00am
- Days - 5:45am - 6:00pm
Each shift is a 12-hour shift, with a rotating schedule (commonly referred to as a 2-2-3-2 schedule): - Nights - 5:45pm - 6:00am
- Days - 5:45am - 6:00pm
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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.
- Conforms with and abides by all regulations, policies, work procedures, instruction, and safety rules.
- Complies with the company’s safety policy at all times
- Complies with the company’s quality policy at all times
- Exhibits regular, reliable, punctual and predictable attendance.
- May be required to work mandatory overtime and/or irregular hours and/or on irregular days to complete assignments and meet business needs.
- Performs other duties as assigned.
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
Travel Requirements:
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