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Operates department machine and equipment according to Standard Operating Procedures (SOPs), Machine Setup (MS), Manufacturing Procedure (MP) instructions, job orders, specifications, engineering drawings, and job order special instructions. Maintains quality system requirements for medical device manufacturer according to ISO 13485 and FDA 21 CFR 820.
Adheres to Good Manufacturing Practices (GMPs) and Good Documentation Practices (GDP)
Reads work order and/or engineering drawings and manufacturing specifications to produce product as required
Communicates with co-workers and supervisors to receive instructions and coordinate activities along with job order performance
Visually inspects or measures in-process and finished product for specified quality attributes
Completes work orders and other related Device History Record (DHR) paperwork as required
Supports 5S, Lean Six Sigma, and continuous improvement projects within the department and facility to support quality objectives, along with customer and business needs
Other duties may be assigned in different areas of the department, employee must be able to multi-task.
Employee will be trained to operate department machinery, must meet productivity standards and maintain good quality of work produced.
Must be punctual and report to work station on time. Good attendance is a requirement.
Practice good housekeeping and be well organized.
Follow rules of conduct, dress code, PPE (personal protective equipment) must be practiced always.
SKILLS & ABILITIES:
Employee must meet quality standards of productivity set by the company
Occasional decision making regarding quality of product produced
Must be able to work in different areas of the dept. and learn new job skills
Must be able to work with others in group setting
REQUIRED QUALIFICATIONS (EDUCATION AND EXPERIENCE):
One (1) to three (3) years related experience and/or training or equivalent combination of education and experience
Must speak/read/write English
Must be familiar with Good Manufacturing Practices (GMP)/Quality System Regulations (QSR)/Good Documentation Practices (GDP) Great Attention to detail
Must be organized, have initiative, and ability to work well and cooperate with all levels of the department
Personal Protective Equipment: Eye protection & special clothing
Frequent handling & grasping, weight from 1lb-5lbs
Machine Paced Work
Your success starts with the right career opportunity. Aerotek uses a people-focused approach to connect job seekers to incredible opportunities with leading organizations. Established in 1983, we've grown to become a consistent Best of Staffing winner for talent satisfaction because of our dedication to exceptional service. Serving over 300,000 contract workers every year, we specialize in placing workers with engineering, scientific, professional and industrial skill sets. Aerotek is proud to offer competitive benefits, including contributory medical, dental and vision insurance, weekly pay, discounts on consumer goods and services and more.