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Orchid Orthopedic Solutions · 5 hours ago

QC Inspector, DHR

Arab, AL

Full-time

Onsite

New Grad, Entry Level

0+ years exp

Orchid Orthopedic Solutions is a leading company in the orthopedic industry, focusing on advanced machining of complex instruments. They are seeking a Quality Control Inspector I, DHR to ensure compliance with federal regulations and Good Documentation Practices by reviewing paperwork and conducting inspections throughout the manufacturing process.

Asset ManagementManufacturingMedicalPackaging ServicesProduct DesignProject Management

No H1B

Responsibilities

Verifies all Shop Work Order Documents for conformance per Good Documentation Practices requirements

Enter information of DHR errors into internal database

Move product to the next operation once DHR task is complete

Ensure compliance to Orchid requirements in inspection and record keeping. Collect inspection data and report results

Maintain accurate documentation at all times during the manufacturing and inspection process per Good Manufacturing Practices

Perform complete Device History Record review including inspection documentation

Ensure all raw materials received meet specifications

Perform testing and inspection at various stages of production, including visual and dimensional inspection

Ensure customer specifications and other applicable internal external requirements are followed

Use handheld inspection tools for measurement purposes, such as micrometers, calipers, height gages, optical comparator, gage blocks, and dial indicators

Conduct physical inspection of product with gauging such as: Thread gages, plug gages, pin gages, functional gages

Perform visual and/or cosmetic inspection of product following applicable procedure(s) using appropriate light sources. Monitor equipment to ensure proper operation and escalate any equipment-related issues

Communicate potential nonconforming situations to Quality Engineering and Quality Management

Demonstrate an understanding of basic manufacturing concepts and processes

Quarantine non-conforming or potential non-conforming parts or materials

Work modified schedules to support production requirements as necessary

Complete First Article Inspections as well as receiving, in-process, and 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 perform internal manufactured first articles

Advocate for the health and safety of self, co-workers, customers, and the community

Support quality and compliance by adhering to all procedures, work instructions, and forms per the Quality Management Systems (QMS)

Complete all required training