Quality Technician

Quality Technician
Hours: 8am-4:30pm, M-F
Pay Range: $24.00-$28.00 DOE
Direct Hire
Overview Of Job Function
This role is responsible for ensuring incoming materials and returned medical instruments meet established engineering standards and regulatory requirements.
Duties and

Responsibilities Include:

• Process returned items through autoclave and inspection in preparation for return to “available” status. Update associated BOMs.
• Document instrument returns via the Returned Device Analysis (RDA) system
• Interface with Customer Service / Operations to ensure instrument set / incoming material availability as required
• Inspect incoming material and component assemblies against established standards/drawings/inspection procedures and document results
• Review supplier documentation for appropriate certs, document revisions, and interface with suppliers on quality issues as required
• Schedule MRB meetings as required and follow through to ensure completion
• Review inspection procedures and practices for improvement opportunities
• General maintenance of Quality Records and associated documents
• Assist with other special quality projects as needed
• Other duties as assigned

• High School Diploma. Technical degree or certification preferred
• 1+ years of quality experience, medical device, or other regulated industry preferred
• Interpreting engineering drawings and specifications, work instructions, bill of materials
• Application and interpretation of ANSI Y14.5 (geometric dimensioning and tolerancing) and C=0 sampling plans preferred
• Selection and use of inspection tools for dimensional inspection such as caliper, micrometer, pin gages, etc.
• Ability to effectively interface and communicate with others in the organization; both written and oral
• Working knowledge of PC’s pertaining to file management, word processing, database, and spreadsheet software programs
• Experience working under FDA QMSR preferred
• Detail oriented
• Dependable
• Certifications & Licenses: CQI certification preferred
• Physical & Environmental Requirements:
  Lifting boxes up to 30 lbs.

• Enjoy a comprehensive benefits package including medical, dental, vision, 401(k), PTO, HSA/FSA, and more.
  
  Help ensure the quality and safety of medical devices that support patient care.
• Work in a collaborative environment partnering with Quality, Operations, Customer Service, and suppliers.
• Build your career in the growing medical device industry with opportunities for professional development.
• Contribute to continuous improvement initiatives and process enhancements that drive quality excellence.