Senior Quality Control Inspector

OrthAlign, Inc.

Irvine (CA)

On-site

USD 70,000 - 90,000

Full time

8 days ago

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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., a Smart Technologies, growing medical device company, has an immediate opening for a Senior 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:

6+ 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 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