Live chat

Quality Technician

Location

Lehigh Acres, FL

Description

GENERAL STATEMENT OF DUTIES: The Quality Technician will be responsible to conduct origination inspection of incoming parts and supplies used for manufacture of products; verifying dimensional, visual and/or functional requirements of internal machined product and/or processes. The Technician will ensure that all products conform to company standards and specifications. ESSENTIAL DUTIES AND RESPONSIBILITIES: • Perform dimensional and visual inspections established by quality plans. • Recording dimensional findings and maintaining appropriate documentation. • Ensure that established inspection frequencies and AQL levels are completed in a timely fashion. • Reports any issues found to 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. • Perform 1st article inspections. • Documenting non-conformances. • Inspect products using gauges, coordinate measuring machine, scales, and vision prior to shipment. • Reconciles final inspection documentation for shipments. • Supports Calibration, gauge verification and qualification. • Reviews and interpret 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. • Other duties and responsibilities may change at any time with or without notice.

Requirements

QUALIFICATIONS, KNOWLEDGE, AND SKILLS: • Candidate must be self-motivated, have excellent organizational skills, time management and. Technical background. • Must be able read and interpret blue prints. • Working knowledge of domestic and international medical device regulatory requirements (FDA, ISO-13485, MDD 93/42/EEC, Health Canada regulations, etc.) preferred. EDUCATION AND EXPERIENCE: • Two years degree application based in Technical field, or • 5-7 Years’ experience in Quality Assurance / manufacturing experience • Experience with proper metrology practices (use of Micrometers, Calipers, Height Gauges, Pin Gauges), preferred.

Send Resume

Name:
Phone:
email:
Resume:
Captcha:
  • Reload captcha