QC Inspector, Dimensional

Orchid Orthopedic Solutions•Oregon City, OR

21h•Onsite

About The Position

The QC Inspector, Dimensional performs dimensional inspection of products at various stages of manufacture in accordance with established policies, practices, and procedures. The role inspects wax, ceramic, and metal parts produced in-house or by vendors, records inspection results, maintains documentation, and supports quality and compliance throughout manufacturing. The position reports to the Quality Control Supervisor. The inspector performs receiving, in-process, final, packaging, first-article, and customer-return inspections; reviews Device History Records; verifies that raw materials meet specifications; and communicates potential nonconformances to Quality Engineering and Quality Management. The role also supports production through first-piece inspections, trains inspection personnel, and may work modified schedules as production requires. The position is at Orchid’s Oregon City site, which manufactures orthopedic implants and is registered with the FDA. The site operates in accordance with the ISO 13485:2016 standard.

Requirements

High school diploma or equivalent.
No previous work experience required.
Working experience with mathematical ability, data entry, computer knowledge, communication, collaboration, handwriting, accuracy and attention to detail, quality inspection metrology tools, information processing, blueprint reading, GD&T, visual quality assurance, layout inspection, time management, and problem solving.
Authorization to work for any employer in the United States; the employer is unable to sponsor or take over sponsorship of an employment visa.
Ability to provide proof of eligibility to work in the United States through eVerify.
Candidates offered employment may be required to complete a pre-employment background check and drug screening based on position requirements.

Nice To Haves

Experience in a scientific field.
Experience in quality inspection and lean manufacturing.
Technical trade school training or qualification.
American Society for Quality qualification or certification.

Responsibilities

Inspect wax, ceramic, and metal parts made in-house or by vendors against specifications using blueprints, surface plates, precision measuring equipment, and inspection tools.
Complete written reports and forms to record inspection results; collect inspection data and report results.
Ensure inspection and record keeping comply with Orchid requirements and maintain accurate documentation under Good Manufacturing Practices.
Perform complete Device History Record reviews, including inspection documentation.
Ensure received raw materials meet specifications.
Perform visual and dimensional testing and inspections at various stages of production.
Follow customer specifications and applicable internal and external requirements.
Use handheld measurement tools, including micrometers, calipers, height gages, optical comparators, gage blocks, and dial indicators.
Conduct physical inspections using thread, plug, pin, and functional gages.
Perform visual and cosmetic inspections according to applicable procedures using appropriate light sources.
Monitor equipment for proper operation and escalate equipment-related issues.
Communicate potential nonconforming situations to Quality Engineering and Quality Management.
Quarantine nonconforming or potentially nonconforming parts or materials.
Complete first-article inspections and receiving, in-process, final, and packaging inspections against customer requirements with minimal supervision.
Train inspection personnel.
Inspect customer-returned parts.
Under guidance, perform first-piece inspections to support production and inspect internally manufactured first articles.
Support health and safety for self, coworkers, customers, and the community.
Support quality and compliance by following QMS procedures, work instructions, and forms, and complete required training.
Work modified schedules as needed to support production requirements.