Senior Medical Device Quality Engineer - FPY & CAPA Lead

Creative Solutions Services, LLC; Reedsville (PA); Vor Ort; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

Creative Solutions Services, LLC seeks an experienced Manufacturing Quality Engineer to lead quality assessments, remediation, validation, and continuous improvement in a regulated medical device environment.

The role requires extensive experience with CAPA, nonconformances, process validation (IQ/OQ/PQ), and risk management, with a focus on FDA 21 CFR Part 820, ISO 13485, and PFMEA. You will collaborate across manufacturing teams to reduce defects and drive quality performance.

Qualifikationen

• 8+ years of medical device quality experience.
• Class II/III medical device experience.
• FDA 21 CFR Part 820/QMSR knowledge.
• ISO 13485 and ISO 14971 expertise.
• Experience with CAPA and nonconformance management.
• Strong validation experience (IQ/OQ/PQ) and TMV.

Aufgaben

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

Kenntnisse

Quality management

Regulatory compliance

Process improvement

Risk management

Ausbildung

Engineering degree

Tools

CAPA system

QMS

SPC

PFMEA

Jobbeschreibung

Creative Solutions Services, LLC seeks an experienced Manufacturing Quality Engineer to lead quality assessments, remediation, validation, and continuous improvement in a regulated medical device environment.

The role requires extensive experience with CAPA, nonconformances, process validation (IQ/OQ/PQ), and risk management, with a focus on FDA 21 CFR Part 820, ISO 13485, and PFMEA. You will collaborate across manufacturing teams to reduce defects and drive quality performance.