Quality Control Technician
LeMaitre•North Brunswick Township, NJ
•Onsite
About The Position
The person in this position will uphold and improve the product quality of medical devices manufactured and meet regulatory requirements for compliance. Apply best practices from within the field of quality to ensure that the materials, components, processes, and manufacturing techniques are used to produce high quality and reliable products.
Requirements
- High School Diploma, or equivalent.
- Over 5 years of equivalent experience in a related field, preferably in Medical Device
- Experience in using MS Word, Excel, Power Point and Outlook
- Strong oral and written communication skills
Nice To Haves
- Associate’s degree, preferred
Responsibilities
- Responsible for the proper selection, inspection, and document review of all raw materials, in compliance with approved specifications
- Inspect items to parameters listed on drawings or quality/material specifications
- Adeptly read and/or utilizing pin gauges, rulers, micrometers, calipers, microscopes, and other inspection equipment
- Initiate nonconforming material reports or notices for items not meeting applicable specifications
- Perform manufacturing audits to ensure that manufacturing procedures are properly followed and that products are tested in accordance with approved test plans
- Maintain security and integrity of quarantined components and devices
- Execute activities associated with inspection methods, calibration, maintenance, and record keeping
- Perform data collection and limited data analysis
- Coordinate calibration activities as necessary
- Coordinate and conduct rework and inspection and testing of materials and/or finished goods, as needed, to verify that they meet specifications
- Assist with administrative functions and supports other department tasks as needed
- Perform and assist with incoming material receipt and disposition. Notifies Quality and Operations of all nonconformances
- Issue batch records and production work orders
- Review production documentation for labeling compliance on current products
- Review quality and manufacturing records for completion and accuracy
- Participate in documentation scanning / archiving processes
- Perform and assist with facility environmental control data collection and ensures conformity is achieved
- Perform periodic scheduled and unscheduled walk-through review of the manufacturing process, warehouse storage, and associated production areas to ensure that cGMPs are being followed
- Additional duties, as requested
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
