Senior Quality Engineer - Medical Devices (CAPA, FDA/ISO)

Michael Page; Valley View (OH); Sur place; USD 117 000 - 143 000; Plein temps

Avantages offerts par ce poste

Medical

Vision

More!

Résumé du poste

Michael Page seeks a Quality Engineer to support medical device manufacturing, ensuring FDA and ISO 13485 compliance. You will lead CAPA, risk assessments, and cross-functional efforts to drive product quality and patient safety.

The role emphasizes supplier qualification, Design Control collaboration, and process validation in a highly regulated environment. A strong engineering background and 5–7 years of relevant experience are preferred.

Qualifications

• Bachelor’s degree in an engineering discipline pertinent to medical devices.
• 5–7 years of experience in Manufacturing or Quality Engineering.
• Experience supporting FDA-regulated medical devices and ISO 13485.
• Knowledge of Design History Files, DHF/DMR/DHR and Design Control requirements.

Responsabilités

• Support the launch and ongoing manufacturing of medical devices with domestic contract manufacturers to meet quality, delivery, and performance objectives.
• Provide production support for existing product lines through supplier qualification and CAPA execution.
• Collaborate with Product Development to ensure Design Control compliance throughout the lifecycle.
• Contribute to Design for Manufacturability and reliability initiatives, and cost optimization.
• Lead root cause investigations and implement corrective actions to prevent recurrence.
• Develop and execute process validation and production qualification activities to meet regulatory standards.

Connaissances

Quality engineering

Root cause analysis

CAPA management

Cross-functional collaboration

Regulatory compliance

Process improvement

Project management

Formation

Bachelor's degree in Mechanical Engineering

Bachelor's degree in Biomedical Engineering

Bachelor's degree in Materials Science

Outils

QMS (ISO 13485)

FDA QSR (21 CFR 820)

Description du poste

Michael Page seeks a Quality Engineer to support medical device manufacturing, ensuring FDA and ISO 13485 compliance. You will lead CAPA, risk assessments, and cross-functional efforts to drive product quality and patient safety.

The role emphasizes supplier qualification, Design Control collaboration, and process validation in a highly regulated environment. A strong engineering background and 5–7 years of relevant experience are preferred.