This role is responsible for performing precise mechanical inspections, maintaining compliance with FDA and ISO 13485 standards, and partnering with cross-functional teams to ensure product quality and integrity throughout the manufacturing process.
Responsibilities
Perform dimensional, visual, and functional inspections of components, subassemblies, and finished assemblies
Conduct First Article (FAI), in-process, final, and RMA inspections
Maintain calibrated equipment in the Quality Control Lab and assist with internal calibrations
Generate and maintain part-specific inspection forms and quality documentation
Support inspection activities for R&D projects and new product development
Interpret engineering drawings, specifications, and GD&T symbols to verify compliance
Document and process non-conforming issues and support investigations
Provide inspection records for internal and external audits
Collaborate with suppliers for technical information and product verification
Participate in continuous improvement efforts to enhance accuracy and efficiency
MUST HAVES:
High school diploma or equivalent
Minimum 7 years of experience in Quality Control; medical device experience a plus
Strong background in mechanical inspection, calibration, and metrology
Proficient in interpreting GD&T and mechanical drawings
Skilled in using inspection tools such as calipers, micrometers, microhite, pin gages, and thread gages
Familiar with ERP/MRP systems and electronic quality management systems (eQMS)
Basic understanding of IPC standards for inspections
Numbers & Facts
Location
Littleton, Massachusetts
Skills
Calibrationunmatched
Continuous Improvementunmatched
Cross-Functionalunmatched
Documentationunmatched
ERP (Enterprise Resource Planning)unmatched
Engineering Drawingunmatched
Equipment Maintenance/Repairunmatched
External Auditunmatched
FDA (Food and Drug Administration)unmatched
Geometric Dimensioning and Tolerancingunmatched
High School Diplomaunmatched
IPC Standardsunmatched
ISO (International Organization for Standardization)unmatched
Internal Auditunmatched
Laboratory Managementunmatched
Maintain Complianceunmatched
Manufacturing/Industrial Processesunmatched
Medical Equipmentunmatched
Metrologyunmatched
Product Developmentunmatched
Quality Controlunmatched
Quality Managementunmatched
Research & Development (R&D)unmatched
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