Product Quality Engineer II

POSITION SUMMARY

The Manufacturing technician will be responsible for production and post-processing of medical devices. Common secondary processes include deburring, media blasting, polishing, filing, cleaning, and packaging.

Monday - Friday, 2:00 pm - 10:30 pm

PRINCIPAL RESPONSIBLITIES

Perform production activities for equipment set-up/line clearance, processing, labeling, and record completion while following quality system guidelines and Good Manufacturing Practices (GMP)

Support equipment maintenance activities as needed

Participate in continuous improvement projects

Perform inspections for components and product at all stages of manufacturing process

Compliance to safety (OSHA), GMP, GDP, GLP and 21 CFR 820

EXPERIENCE

High school diploma or GED required

Associates or post-secondary education preferred

Experience in the use of basic machine shop tools and equipment is required

Mechanically inclined

Working knowledge of GMP, GLP, and GDP is required

Strong verbal and written communication

Experience in FDA 21 CFR 820 Quality system is preferred

TOOLS AND EQUIPMENT

Basic hand tools

Rotary tools

Polymeric 3D printers

Media blasting cabinet

Furnace or ovens

Materials testing frames

Additive Device

Cleaning and inspection equipment

Sealing and packaging equipment

Respirator, protective clothing, eye protection, and hearing protection

MATERIALS HANDLING / EXPOSURE

Position may involve handling of or exposure to metallic powders and other powder materials, polymeric resins, cleaning solutions, inert gases, and acids

PHYSICAL ACTIVITIES

Position requires the ability to intermittently lift and carry up to 50 pounds

PPE including eye protection, hearing protection, and gowning required depending on task performed

May require extended periods of standing, extensive work with the operator's hands and tools, as well as occasional squatting, kneeling, and working with a ladder

restor3d is an equal opportunity employer