Sr. Quality Control Inspector

2 hours ago

Irvine, California, United States OrthAlign Inc. Full time

OrthAlign, Inc., a Smart Technologies, growing medical device company, has an immediate opening for a Sr. Quality Control Inspector. This role supports all quality initiatives and is responsible for quality control inspection of incoming materials and in-process manufacturing.  This position supports audits and reviews/analyzes data and documentation.

You will:

  • Perform dimensional, visual and functional inspections of raw materials, components, finished assemblies and in-process manufacturing work.
  • Document inspection results clearly and completely.
  • Disposition materials and enter transactions in our ERP system.
  • Review supplier test results and First Article Inspections (FAI) reports.
  • Support RA/QA associates on defect awareness, inspection methods and specification requirements.
  • Maintain knowledge of all procedures and changes to specifications related to areas of responsibilities.
  • May perform First Article inspections.
  • Review Device History Records (DHRs) for product release.
  • Write and distribute non-conformance reports (NCMRs) for nonconformances found during inspection. 
  • Inspect various plastic and metal components, mechanical instruments, circuit boards, electro-mechanical assemblies, labels and packaging materials

You need:

  • Ÿ6+ years Inspection experience in medical device or similar industry (i.e., aerospace, automotive or other highly technical, regulated and rapid-paced environment)
  • Excellent written and verbal communication skills
  • Ability to work as a collaborative team member as well as independently
  • Flexibility and strong organizational skills with ability to prioritize multiple tasks
  • Experience using calipers, micrometers, height gages, gage blocks, microscopes and similar inspection tool
  • Experience with ERP / MRP software systems, especially conducting material transactions
  • Ability to initiate and manage time effectively without direct supervision
  • To know how to read and interpret engineering drawings, ANSI-Y-14.5 Dimensioning and Tolerancing
  • Sound judgment when making decisions and communicating with peers and management
  • Excellent attention to detail, producing high quality output appropriate
  • To be results-oriented with appropriate urgency and follow-up

We offer:

  • Competitive compensation including bonus and equity
  • Opportunities for career advancement
  • Full benefits package
  • An evolving, engaging culture and workplace
  • Nominated by our employees as a Top Place to Work in Orange County

It is an exciting time at OrthAlign - make your next career move with us

Please note that we are unable to provide any type of sponsorship at this time.

Location

Irvine, California

Department

300 - RA & QA

Employment Type

Full-Time

Minimum Experience

Mid-level

Compensation

$30/hr + DOE

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