Senior Quality Engineering Manager - Medical Devices

Legacy MEDSearch; Chicago (IL); On-site; USD 150,000 - 230,000; Full time

Benefits offered by this job

Performance-based incentive

Job summary

Legacy MEDSearch is seeking a Senior Manager of Quality Engineering to own the Quality function and lead a critical manufacturing transfer initiative for a Class II medical device. You will oversee the QMS, drive supplier quality activities, and partner with Operations, Regulatory, and Supply Chain to ensure a smooth transfer to new contract manufacturers.

The ideal candidate combines hands-on quality leadership with strategic vision in a small-company setting, being comfortable directing

Qualifications

• Extensive experience with Class II medical devices and QMS oversight.
• Proven ability to lead manufacturing transfers and supplier changes.
• Strong knowledge of FDA QSR, Design Controls, and MDR/ISO 13485 concepts.
• Experience qualifying contract manufacturers and sterilization providers.
• Excellent program management and cross-functional leadership.

Responsibilities

• Lead quality activities for evaluation, audit, qualification, and onboarding of new contract manufacturers and critical suppliers.
• Own the Quality portion of manufacturing transfer projects, including process validation, production controls, inspection methodologies, acceptance criteria, traceability, DMR, DHR, and change management.
• Develop and manage supplier quality systems including supplier monitoring, supplier audits, quality agreements, SCARs, nonconformances, and CAPAs.
• Serve as the Quality lead during supplier and manufacturing qualification efforts.
• Own and continuously improve the company’s Quality Management System.
• Manage document control, change control, training programs, internal audits, management reviews, product release activities, and quality records.
• Oversee complaint handling, vigilance activities, MDR reporting, and post-market quality processes.
• Ensure FDA inspection readiness and support regulatory audits and inspections.
• Partner cross-functionally with Operations, Manufacturing, Supply Chain, and Regulatory teams to support business and quality objectives.
• Drive quality metrics, risk management activities, and continuous improvement initiatives.
• Maintain hands-on involvement in daily Quality operations rather than functioning solely as a people manager.

Skills

Quality management

Regulatory compliance

Design Controls

Supplier quality

CAPA

Project management

Cross-functional leadership

Job description

Legacy MEDSearch is seeking a Senior Manager of Quality Engineering to own the Quality function and lead a critical manufacturing transfer initiative for a Class II medical device. You will oversee the QMS, drive supplier quality activities, and partner with Operations, Regulatory, and Supply Chain to ensure a smooth transfer to new contract manufacturers.

The ideal candidate combines hands-on quality leadership with strategic vision in a small-company setting, being comfortable directing