Mack Prototype, Inc.
Overview
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.
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
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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.
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
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