Quality engineer

Programmers.io; Reedsville (PA); On-site; USD 120,000 - 160,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

Manufacturing Quality Engineering

Process Validation and TMV

SPC, MSA, and PFMEA

CAPA and Nonconformance Management

FDA 21 CFR Part 820, ISO 13485, ISO 2

Education

Bachelor's/Master's degree in Engineering

Job description

Lead manufacturing quality assessment, remediation, and continuous improvement initiatives for Class II/III medical devices. Evaluate manufacturing processes, process validations, risk management activities, supplier quality systems, and compliance to FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, and MDSAP requirements. Drive yield improvement, CAPA effectiveness, quality metrics review, and manufacturing risk reduction programs across regulated manufacturing environments.

Key Responsibilities:

• 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

Required Skills:

• Manufacturing Quality Engineering.
• Process Validation and TMV.
• SPC, MSA, and PFMEA.
• CAPA and Nonconformance Management.
• FDA 21 CFR Part 820, ISO 13485, ISO 14971

Preferred Qualifications:

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