Quality Technician

About Us:

We are a leading provider of prototype and low-volume production services specializing in 3D printing, urethane casting, CNC machining, and plastic injection molding. We serve high-demand industries including medical, defense, and industrial markets. We are ISO 13485 certified and committed to delivering high-quality, precision components.

Position Summary:

We are seeking a skilled Quality Technician with hands-on experience in CMM programming and operation, plastic molding inspection, and regulated quality systems. The ideal candidate will support our quality assurance efforts by performing AQL inspections, first article inspections, PPAPs, validation protocols, and ensuring compliance with ISO 13485 standards.

Key Responsibilities:

• Program and operate CMMs (preferably PC-DMIS or similar) to inspect precision components


• Conduct first article inspections (FAI), in-process inspections, and final inspections using appropriate tools and methods


• Prepare and maintain documentation for PPAP, IQ/OQ/PQ validations, and device history records (DHR)


• Support quality system maintenance, internal audits, and corrective/preventive actions (CAPA)


• Interpret 2D drawings, GD&T, and customer specifications to validate conformance


• Assist in maintaining calibration systems for gages, fixtures, and inspection equipment


• Collaborate with production, engineering, and quality teams to resolve quality issues


• Support customer and regulatory audits


• Ensure compliance with ISO 13485, FDA QSR, and customer-specific requirements

Qualifications:

• 3+ years of experience in a manufacturing environment (preferably in plastic injection molding or medical devices)


• Proficient in CMM programming and operation (PC-DMIS, Calypso, or equivalent)


• Strong understanding of GD&T, blueprint reading, and metrology tools


• Experience with PPAP, FAI, and validation protocols (IQ/OQ/PQ)


• Familiarity with ISO 13485, FDA, or other regulated quality systems


• Working knowledge of Microsoft Office and quality documentation systems


• Excellent attention to detail and documentation accuracy


• Strong communication and problem-solving skills

Preferred Qualifications:

• Associate’s degree in Engineering Technology, Quality, or related field


• ASQ certification (CQT or CQI) is a plus


• Experience with statistical process control (SPC), Minitab, or similar tools

Benefits:

• Competitive pay


• Health and dental insurance


• 401(k) with company match


• PTO and paid holidays


• Growth and training opportunities