Manufacturing Technician, Clean and Pack, 2nd Shift

restor3d•Durham, NC

2d•Onsite

About The Position

The Manufacturing Technician position is responsible for operating production equipment in a productive manner while maintaining a high level of quality in the manufacturing of restor3d implants and components. 2nd Shift - Monday - Fri, 2:00 pm - 10:30 pm

Requirements

High School Diploma, GED, or equivalent work experience; work experience in a medical device and/or regulated environment preferred
Familiarity with Oracle (or equivalent) ERP systems and Microsoft Office Applications
Familiar with ISO Standards and Good Manufacturing Practices
Good verbal and written communication
Demonstrated English reading and writing skills
Good written and verbal communication skills.
Demonstrated ability to monitor own work to ensure quality, accuracy and thoroughness.
Strong organizational, analytical and time-management skills.
Able to self-motivate and work both independently and as part of a team.
Manual dexterity to handle tools, inspection gauges and equipment of different sizes.
Demonstrated organizational skills.
Ability to work in a fast-paced environment and multitask.
Comfortable with change.
Ability to work as part of a team as well as independently.
Ability to lift, pull and push up to 40 lbs
Ability to stand for prolonged periods of time
Ability to work in a Class 10,000 or ISO class VII clean room environment for prolonged periods of time
Busy work environment with frequent interruptions
Flexible to work overtime, extended hours and weekends as business demands
Must be aware of hazards within the company; adhere to quality and safety standards established by FDA and other regulatory agencies
Able to work in changing environments (reduced lighting, increased noise, temperature variances, unpleasant odors, dust etc.).

Nice To Haves

Shipping/receiving/stockroom experience a plus.

Responsibilities

Develop and maintain strong, internal working relationships across restor3d.
Understand the objectives, responsibilities, and mission of the Manufacturing department and works towards those goals.
Prioritize and plan work activities; adapt for changing conditions.
Execute daily maintenance and start-up activities.
Perform machine set-ups.
Operate machinery and processing equipment, including but not limited to clean line and pouch sealers,
Perform inspection of components and assembly as required.
Perform cleaning, pouching/sealing and labeling
Strict adherence to Good Documentation Practices when executing all assignments.
Perform timely and accurate transactions of workflow in ERP system.
Participate in inventory cycle counts, variance investigation and reconciliation.
Assist in the investigation and implementation of corrective actions on product and process failures.
Comply with all company policies and procedures including safety regulations, personal protective equipment requirements, Standard Operating Procedures, Work Instructions and Good Manufacturing Procedures.
Responsible for upkeep of manufacturing areas and provide a clean and safe work environment.
Review all manufacturing documentation, assembly, inspection, test, packaging procedures and provide feedback.
Other duties as assigned.