Senior Quality Control Inspector - Medical Devices

OrthAlign, Inc.; Irvine (CA); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Bonus

Equity

Benefits

Culture

Top Workplace OC

Job summary

OrthAlign, Inc. in Irvine, CA is seeking a Senior Quality Control Inspector to support quality initiatives and perform inspections of incoming materials, in-process manufacturing and finished assemblies.

You will document results, disposition materials, review DHRs and FAIs, and assist RA/QA on defect awareness and specifications, while maintaining procedures and complying with ANSI-Y-14.5. The role requires hands-on use of calipers, micrometers, height gauges and other inspection tools, with

Qualifications

• 6+ years inspection experience in medical device or similar industry.
• 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.
• To know howto 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.

Responsibilities

• 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

Skills

Inspection

Medical devices

Communication

Teamwork

Time management

Drawing interpretation

ERP/MRP

Tools

Calipers

Micrometers

Height gauges

Gage blocks

Microscopes

ERP/MRP

Job description

OrthAlign, Inc. in Irvine, CA is seeking a Senior Quality Control Inspector to support quality initiatives and perform inspections of incoming materials, in-process manufacturing and finished assemblies.

You will document results, disposition materials, review DHRs and FAIs, and assist RA/QA on defect awareness and specifications, while maintaining procedures and complying with ANSI-Y-14.5. The role requires hands-on use of calipers, micrometers, height gauges and other inspection tools, with