Quality Engineer - Medical Devices, Regulatory & CAPA Lead

Programmers.io; Reedsville (PA); Sur place; USD 120 000 - 160 000; Plein temps

Résumé du poste

Programmers.io in Pennsylvania seeks a Lead Manufacturing Quality Engineer to drive assessment, remediation, and continuous improvement for Class II/III medical devices. You will oversee process validations, risk management, CAPA, supplier quality, and regulatory compliance with FDA 21 CFR Part 820, ISO 13485, ISO 14971, and MDSAP.

Responsibilities include leading quality assessments and audits, driving FPY and defect reduction, reviewing IQ/OQ/PQ, managing CAPA and nonconformances, and

Qualifications

• Bachelor's or Master's degree in Engineering.
• 8+ years of Medical Device Manufacturing Quality experience.
• Experience with Class II/III devices.
• Experience supporting regulatory audits.

Responsabilités

• Lead manufacturing quality assessments and process audits.
• Drive FPY improvement and defect reduction initiatives.
• Review process validation (IQ/OQ/PQ) and risk management activities.
• Manage CAPA, nonconformance, and supplier quality issues.
• Support FDA, ISO 13485, MDSAP, and regulatory audits.

Connaissances

Manufacturing Quality Engineering

Process Validation and TMV

SPC, MSA, and PFMEA

CAPA and Nonconformance Management

FDA 21 CFR Part 820, ISO 13485, ISO 2

Formation

Bachelor's/Master's degree in Engineering

Description du poste

Programmers.io in Pennsylvania seeks a Lead Manufacturing Quality Engineer to drive assessment, remediation, and continuous improvement for Class II/III medical devices. You will oversee process validations, risk management, CAPA, supplier quality, and regulatory compliance with FDA 21 CFR Part 820, ISO 13485, ISO 14971, and MDSAP.

Responsibilities include leading quality assessments and audits, driving FPY and defect reduction, reviewing IQ/OQ/PQ, managing CAPA and nonconformances, and