Role: Quality engineer Location: Reedsville, PA (Day 1 Onsite)
Job Summary:
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
Numbers & Facts
Location
Reedsville, PA
Skills
Code of Federal Regulationsunmatched
Continuous Improvementunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
FDA (Food and Drug Administration)unmatched
Healthcare Qualityunmatched
ISO (International Organization for Standardization)unmatched
Manufacturingunmatched
Manufacturing Analysisunmatched
Manufacturing/Industrial Processesunmatched
Medical Equipmentunmatched
Process Failure Mode and Effects Analysis (PFMEA)unmatched
Process Improvementunmatched
Process Validationunmatched
Productivity Managementunmatched
Quality Engineeringunmatched
Quality Metricsunmatched
Regulationsunmatched
Risk Managementunmatched
Vendor/Supplier Quality Managementunmatched
🎯
Be found by employers
5,500+ employers search our resume database daily. Add yours to get found by recruiters looking for candidates like you.
Level up your application
Professional resume templates
Browse dozens of recruiter approved resume templates, layouts and formats. Choose your favorite and make it your own in minutes.