Quality Technician

Drive Medical•Lehigh Acres, FL

21d•Onsite

About The Position

Drive DeVilbiss is a leading manufacturer of medical products with a strong track record of growth. The Quality Technician will be responsible for conducting origination inspection of incoming parts and supplies used for the manufacture of products, and verifying dimensional, visual, and/or functional requirements of internal machined products and/or processes. The Technician will ensure that all products conform to company standards and specifications.

Requirements

Must be self-motivated, have excellent organizational skills, time management skills and technical background.
Must be able read and interpret solid works drawings.
Ability to frequently sit, stand, bend, or walk an entire shift.
Frequently required to use hands to finger, handle, or feel objects.
Ability to regularly lift and/or move up to 25 pounds, repetitively.
Two years degree application based in Technical field, or 5-7 Years’ experience in Quality Assurance / Manufacturing experience.

Nice To Haves

Working knowledge of domestic and international medical device regulatory requirements (FDA, ISO-13485, MDD 93/42/EEC, Health Canada regulations, etc.) preferred.
Experience with proper metrology practices (use of Micrometers, Calipers, Height Gauges, Pin Gauges), preferred.

Responsibilities

Performs dimensional and visual inspections established by quality control plans.
Records dimensional findings and maintaining appropriate documentation.
Ensures compliance to established inspection frequencies and AQL levels.
Ensures all inspections are completed in a timely fashion.
Reports any issues found with product quality to the Manager and/or Quality Engineer.
Works with operators on a daily basis with part handling with respect to critical components in assuring that products are packaged, handled and moved by established procedures.
Ensures that all documentation and operations have been completed prior to movement to next operation.
Performs 1st article inspections.
Documents non-conformances.
Inspects products using gauges, coordinate measuring machine, scales, and visual inspection prior to shipment.
Reconciles final inspection documentation for shipments.
Reviews and interprets product and component drawings and supplier documentation.
Performs tasks in accordance with applicable requirements of the FDA Quality System Regulation, ISO 13485, MDD, CMDCAS and any other applicable regulations.