Senior Quality Engineer

Employer Overview

A growing company in the dental and medical devices industry, specializing in dental products and accessories for dental implants, prosthetics, and related treatments. The company is expanding its presence and building strong manufacturing capabilities to serve dental professionals and healthcare providers.

Job Summary

We are seeking a Senior Quality Engineer to control product and manufacturing quality activities, with a strong focus on precision inspection, metrology, GD&T, process quality, and nonconformance management. The role will also support the development and maintenance of the Quality Management System.

Key Responsibilities

• Perform and control Incoming, First Article, In-Process, and Final Inspection activities.
• Review engineering drawings, specifications, tolerances, and GD&T and define appropriate inspection methods.
• Perform precision dimensional inspection using optical/vision systems, microscopes, gauges, micrometers, and other metrology equipment.
• Develop and maintain Inspection Plans, Control Plans, inspection criteria, and measurement records.
• Monitor manufacturing quality using SPC, Cp/Cpk, trend analysis, and process capability data.
• Identify and control nonconforming products and lead root-cause investigations.
• Participate in CAPA, PFMEA, process validation, and continuous improvement activities.
• Manage calibration and verification of measuring and inspection equipment.
• Support supplier and incoming material quality evaluation.
• Analyze quality data, recurring defects, scrap, and process deviations and recommend corrective actions.
• Ensure traceability and quality records throughout the manufacturing process.
• Support ISO 13485 implementation, audits, and regulatory inspections.
• Train Production and Quality personnel on inspection methods, measurement techniques, GD&T, and quality requirements.

Qualifications

• Bachelor's degree in Mechanical, Production, Manufacturing, or Quality Engineering.
• 5+ years of Quality Engineering experience.
• Experience in precision manufacturing, medical devices, automotive, aerospace, or other high-precision industries is preferred.
• ISO 13485 / medical-device quality experience is strongly preferred.
• Strong knowledge of GD&T, engineering drawings, dimensional tolerances, and precision metrology.
• Strong hands-on experience with measurement and inspection equipment.
• Knowledge of SPC, Cp/Cpk, MSA, Gauge R&R, Control Plans, PFMEA, NCR, CAPA, and Root Cause Analysis.
• Good understanding of CNC machining and manufacturing processes.
• Experience with optical/vision measurement systems is an advantage.
• Strong analytical and problem-solving skills.
• Strong documentation skills.
• Strong attention to detail.
• Good decision-making abilities.
• Ability to train and guide other employees.