Senior Quality Engineer, Medical Devices - Design Controls

Katalyst-Healthcares-; Cincinnati (OH); On-site; USD 110,000 - 140,000; Full time

Job summary

Katalyst-Healthcares- is seeking an experienced Senior Quality Engineer focused on medical devices to lead quality activities across development, design controls, transfers, and sustaining operations.

The role emphasizes risk management, V&V, CAPA, and regulatory compliance with FDA and ISO standards. A strong background in Class II/III devices and cross-functional collaboration is required.

Qualifications

• 8+ years of quality engineering experience in the medical device industry.
• 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.
• Experience supporting FDA and ISO audits and regulatory inspections.

Responsibilities

• Develop, review, and approve quality plans, product specifications, engineering changes, and development deliverables.
• Lead design control activities in compliance with FDA and ISO requirements.
• Develop and maintain risk management documentation (DFMEAs, PFMEAs, ISO 14971).
• Review and approve Design Verification and Validation (V&V) protocols and reports.
• Support equipment and manufacturing process validation (IQ/OQ/PQ).
• Lead investigations into nonconformances and deviations; drive CAPA.
• Perform root cause analysis using structured methodologies.
• Apply statistical techniques for process capability studies and MSA.
• Develop and update SOPs, work instructions, and quality-system documentation.
• Support internal and regulatory audits; contribute to post-market surveillance and complaint analysis.
• Collaborate with cross-functional teams for manufacturing transfers, new launches, and sustaining engineering activities.

Skills

Quality Engineering

FDA/ISO regulatory

CAPA & RCA

DFMEA / PFMEA

V&V protocols

Risk Management (ISO 14971)

Statistical methods (MSA, SPC)

Cross-functional collaboration

Education

Bachelor's degree in Engineering

Master's degree preferred

Job description

Katalyst-Healthcares- is seeking an experienced Senior Quality Engineer focused on medical devices to lead quality activities across development, design controls, transfers, and sustaining operations.

The role emphasizes risk management, V&V, CAPA, and regulatory compliance with FDA and ISO standards. A strong background in Class II/III devices and cross-functional collaboration is required.