Quality Engineer

Cincinnati, OH

Instant Apply

4 days ago

Job Description

Job Summary
We are seeking an experienced Senior Quality Engineer to support medical-device quality systems, product development, design controls, risk management, process validation, and regulatory compliance. The ideal candidate will have strong hands-on experience in CAPA, root cause analysis, non-conformance investigations, design verification and validation, and compliance with applicable FDA regulations and ISO standards.

Roles& Responsibilities

Support new product development and maintain quality deliverables in accordance with medical-device design control requirements.
Develop, review, and approve design verification and validation protocols, reports, and support documentation.
Develop and maintain product risk management documentation, including DFMEA, PFMEA, and risk assessments.
Lead and support CAPA, non-conformance, deviation, root cause analysis, and engineering change-control activities.
Execute and review process validation, equipment qualification, and IQ/OQ/PQ activities.
Support internal and external audits, regulatory inspections, and quality system compliance initiatives.
Analyze quality metrics, investigate trends, and support post-market surveillance and customer complaint investigations.
Review engineering drawings, product specifications, tolerances, GD&T requirements, and manufacturing documentation.
Develop and maintain Quality Plans, SOPs, work instructions, and validation documentation.
Collaborate with R&D, Manufacturing, Regulatory Affairs, Supplier Quality, and cross-functional engineering teams.
Support technical transfers, manufacturing transfers, and process implementation while ensuring compliance with applicable quality standards.
Drive continuous improvement initiatives to enhance product quality, process capability, and overall quality system effectiveness.

Education & Experience

Bachelor's degree in engineering, Biomedical Engineering, Life Sciences, or a related technical field.
Minimum of 5 years of quality engineering experience in the medical-device industry or another regulated life-sciences environment.
Strong knowledge of FDA Quality System requirements, Good Manufacturing Practices (GMP), and ISO 13485.
Experience with ISO 14971, design controls, and medical-device risk management.
Hands-on experience with CAPA, root cause analysis (RCA), non-conformances, deviations, and change control.

Numbers & Facts

Location

Cincinnati, OH

Skills

Analysis Skillsunmatched
Biologyunmatched
Biomedical Engineeringunmatched
Change Controlunmatched
Continuous Improvementunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Cross-Functionalunmatched
Design Failure Mode and Effects Analysis (DFMEA)unmatched
Design Verificationunmatched
Documentationunmatched
Engineeringunmatched
Engineering Drawingunmatched
Environmental Sciencesunmatched
Equipment Validationunmatched
External Auditunmatched
FDA Requirementsunmatched
GMP (Good Manufacturing Practices)unmatched
Geometric Dimensioning and Tolerancingunmatched
Healthcare Qualityunmatched
ISO (International Organization for Standardization)unmatched
Internal Auditunmatched
Maintain Complianceunmatched
Manufacturing Requirementsunmatched
Manufacturing/Industrial Processesunmatched
Market Trend Analysisunmatched
Medical Equipmentunmatched
Medical Office Administrationunmatched
Process Capabilityunmatched
Process Failure Mode and Effects Analysis (PFMEA)unmatched
Process Improvementunmatched
Process Validationunmatched
Product Designunmatched
Product Developmentunmatched
Product Programsunmatched
Product Requirements Document (PRD)unmatched
Product Supportunmatched
Quality Assuranceunmatched
Quality Engineeringunmatched
Quality Managementunmatched
Quality Metricsunmatched
Quality System Requirements (QSR)unmatched
Regulationsunmatched
Regulatory Complianceunmatched
Research & Development (R&D)unmatched
Risk Analysisunmatched
Risk Managementunmatched
Root Cause Analysisunmatched
Standard Operating Procedures (SOP)unmatched
Support Documentationunmatched
Surveillanceunmatched
Technical Supportunmatched
Tolerance Analysisunmatched
Trend Analysisunmatched
Validation Documentationunmatched
Validation Planunmatched
Validation Testingunmatched

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