Senior Quality Engineer

Cincinnati, OH

Instant Apply

2 days ago

Job Description

Job Summary
We are seeking an experienced Senior Quality Engineer Medical Devices to lead and support quality engineering activities across medical device product development, design controls, manufacturing technical transfers, and sustaining operations.

Roles and Responsibilities

Develop, review, and approve quality plans, product specifications, engineering changes, and product development deliverables.
Lead and maintain design control activities in accordance with FDA and ISO regulatory requirements.
Develop, review, and maintain risk management documentation, including DFMEAs, PFMEAs, and risk management reports, in compliance with ISO 14971.
Review and approve Design Verification and Validation (V&V) protocols, reports, and related documentation.
Support equipment and manufacturing process validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Lead investigations into product nonconformances, process deviations, and quality-related issues.
Drive Corrective and Preventive Actions (CAPA) and conduct structured Root Cause Analysis (RCA) using appropriate problem-solving methodologies.
Apply statistical techniques for process capability studies, sampling plans, Measurement System Analysis (MSA), and process improvement initiatives.
Develop, review, and update Standard Operating Procedures (SOPs), work instructions, and other quality-system documentation.
Support internal, external, and regulatory audits, ensuring compliance with FDA and ISO requirements.
Support post-market surveillance activities, complaint investigations, and complaint-trend analysis.
Collaborate with cross-functional teams to support manufacturing technical transfers, product launches, and sustaining engineering activities .

Education & Experience

Bachelor's degree in engineering, Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Manufacturing Engineering, or a related technical discipline.
Master's degree in engineering, Biomedical Engineering, or a related field is preferred.
Minimum 8+ years of experience in Quality Engineering within the medical device industry.
Strong experience supporting Class II and Class III medical device development and manufacturing.
Hands-on experience with design controls, risk management, and product development quality activities.

Numbers & Facts

Location

Cincinnati, OH

Skills

Biomedical Engineeringunmatched
Corrective Actionunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Cross-Functionalunmatched
Design Verificationunmatched
Documentationunmatched
External Auditunmatched
FDA Requirementsunmatched
ISO (International Organization for Standardization)unmatched
Internal Auditunmatched
Maintain Complianceunmatched
Manufacturingunmatched
Manufacturing Technologyunmatched
Manufacturing/Industrial Processesunmatched
Medical Equipmentunmatched
Medical Productsunmatched
Problem Solving Skillsunmatched
Process Capabilityunmatched
Process Improvementunmatched
Process Validationunmatched
Product Designunmatched
Product Developmentunmatched
Product Engineeringunmatched
Product Planningunmatched
Product/Service Launchunmatched
Quality Engineeringunmatched
Regulationsunmatched
Risk Managementunmatched
Root Cause Analysisunmatched
Standard Operating Procedures (SOP)unmatched
Structured Analysisunmatched
Surveillanceunmatched
Systems Analysisunmatched
Technical Supportunmatched
Trend Analysisunmatched
Validation Testingunmatched

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