Biogen is seeking a Manager of Device Quality Systems who will play a critical role in ensuring regulatory compliance for Class III medical devices. The ideal candidate should have significant experience in medical device quality systems, particularly with Class III implantable devices, and be adept at fostering a culture of quality and continuous improvement
Job Summary
This role is pivotal in ensuring regulatory compliance and supporting quality across the lifecycle of Class III medical devices.
The position involves developing, implementing, and executing quality system activities aligned with FDA QMSR, ISO 13485, and EU MDR.
Biogen offers a competitive benefits package including up to $10,000 per year in tuition reimbursement and paid parental leave.
Matching Summary
Match Score: 85
Biogen is seeking a Manager of Device Quality Systems who will play a critical role in ensuring regulatory compliance for Class III medical devices. The ideal candidate should have significant experience in medical device quality systems, particularly with Class III implantable devices, and be adept at fostering a culture of quality and continuous improvement.
Salary
Base: $111,000.00-$149,000.00; Bonus/Equity: Short-term cash bonus and equity incentive opportunities available; Benefits: Medical, Dental, Vision, Life insurance, 401(k) match, Tuition reimbursement up to $10,000
Skills & Requirements
Must-have
FDA Quality Management System Regulation (QMSR)
ISO 13485 standards knowledge
Class III implantable device experience
Supplier audit leadership
CAPA activity management
Nice-to-have
Strong analytical mindset
Proactive approach to quality culture
Excellent communication skills
Continuous improvement initiatives
Collaborative team environment
Key Requirements
Bachelor's degree in relevant field
At least 5 years in medical device quality systems
At least 2 years with Class III implantable devices
Experience conducting audits and managing supplier qualifications