Senior Medical Device Quality Engineer - CAPA & Process Lead

Katalyst CRO; Reedsville (PA); On-site; USD 95,000 - 125,000; Full time

Job summary

Katalyst CRO seeks an experienced Manufacturing Quality Engineer to lead quality assessments, remediation, validation, and continuous improvement within a regulated medical device manufacturing environment. You will drive FPY improvements, review IQ/OQ/PQ activities, and support risk management across supplier quality.

You will manage CAPA, nonconformances, and apply SPC, MSA, PFMEA tools while supporting FDA, ISO 13485, and MDSAP audits.

Qualifications

• 8+ years of Medical Device Manufacturing Quality experience preferred.
• Class II/III medical device experience.
• Strong process validation and TMV expertise.
• Experience with CAPA and nonconformance management.
• Knowledge of FDA 21 CFR Part 820/QMSR.
• ISO 13485 and ISO 14971 expertise.
• SPC, MSA, PFMEA, and supplier quality experience.
• Engineering bachelor's or master's degree preferred.

Responsibilities

• Lead manufacturing quality assessments and process audits.
• Drive FPY improvement and defect reduction.
• Review process validation activities, including IQ/OQ/PQ.
• Support risk management and PFMEA activities.
• Manage CAPA, nonconformances, and supplier quality issues.
• Apply SPC, MSA, PFMEA, and manufacturing quality tools.
• Support FDA, ISO 13485, and MDSAP audits and inspections.
• Drive manufacturing risk reduction and quality improvement initiatives.

Skills

Medical device quality

Quality engineering

CAPA management

Process validation

Risk management

Education

Engineering bachelor's or master's degree

Tools

SPC

MSA

PFMEA

TMV

IQ/OQ/PQ

Job description

Katalyst CRO seeks an experienced Manufacturing Quality Engineer to lead quality assessments, remediation, validation, and continuous improvement within a regulated medical device manufacturing environment. You will drive FPY improvements, review IQ/OQ/PQ activities, and support risk management across supplier quality.

You will manage CAPA, nonconformances, and apply SPC, MSA, PFMEA tools while supporting FDA, ISO 13485, and MDSAP audits.