Senior Manager Quality Engineering - Medical Device

Legacy MEDSearch; Chicago (IL); Sur place; USD 150 000 - 230 000; Plein temps

Avantages offerts par ce poste

Performance-based incentive

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Quality management

Regulatory compliance

Design Controls

Supplier quality

CAPA

Project management

Cross-functional leadership

Description du poste

Senior Manager Quality Engineering - Neurosurgery - 3686014

Join an innovative medical device company seeking a Senior Quality Manager to take ownership of the Quality function and lead a critical manufacturing transition initiative. This highly visible role will be responsible for overseeing the Quality Management System, driving supplier quality activities, and leading quality efforts associated with the transfer of a commercial Class II medical device to new manufacturing and supply chain partners. The ideal candidate is a hands-on quality professional who thrives in a small-company environment and enjoys balancing strategic quality leadership with day-to-day execution.

Responsibilities:

• Lead Quality activities associated with the evaluation, audit, qualification, selection, 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 activities.
• 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.

Qualifications:

• Strong medical device Quality experience within Class II medical devices required.
• Experience leading or supporting manufacturing transfers, supplier transitions, or contract manufacturer changes strongly preferred.
• Experience qualifying and managing contract manufacturers, sterilization providers, and critical suppliers.
• Working knowledge of FDA Quality System Regulations, Design Controls, and medical device Quality Management Systems.
• Experience with process validation, inspection methods, production controls, DMR, DHR, traceability, and change control.
• Experience managing supplier quality programs, CAPAs, nonconformances, and quality agreements.
• Experience supporting complaint handling, MDR reporting, audits, and FDA inspections.
• Regulatory experience, including 510(k) submissions and regulatory documentation, is a plus.
• Demonstrated ability to operate independently within a small-company environment.
• Strong project management, communication, and cross-functional leadership skills.
• Chicago-based candidates strongly preferred.
• Willingness to travel to contract manufacturers, suppliers, and external partners as needed.

Compensation:

• Performance-Based Incentive Opportunity

The job description is not exhaustive and may have been condensed for online or mobile viewing. It does not encompass all duties, responsibilities, or aspects of the job and is subject to amendments at the sole discretion of the Employer. Employees may also perform other related duties as needed to support the organization.