Senior Manager, Device Quality Systems
About This Role:
As the Senior Manager of Quality Systems within the Implantable Device Unit (IDU), you are pivotal to ensuring regulatory compliance and upholding quality standards across the lifecycle of Class III medical devices. You will lead the development, implementation, and execution of quality system activities, aligning with FDA Quality Management System Regulation (QMSR), ISO 13485, and EU regulations. Your role is essential in maintaining the Quality Management System (QMS) and fostering a culture of quality in device development and lifecycle management.
By collaborating with cross-functional teams, you will drive continuous improvement initiatives and ensure seamless management of quality documentation, audits, and supplier qualifications. You fit into the broader business structure by supporting device quality and compliance, essential for product success and regulatory alignment.
What You’ll Do:
Lead the development and maintenance of the Quality Management System for Class III medical devices.
Manage quality procedures, electronic document control systems, audit programs, CAPAs, training programs, and document control.
Lead regulatory, collaboration partner, and supplier audits to ensure compliance.
Own and manage updates to quality documentation supporting IDU functions.
Drive continuous improvement initiatives within the Implantable Device Unit product QMS.
Schedule and lead supplier qualification activities in accordance with ISO 13485.
Conduct supplier audits to ensure compliance with quality, regulatory, and supplier control standards.
Who You Are:
You are detail-oriented and possess a passion for maintaining high-quality standards. Your commitment to regulatory compliance is unwavering, and you thrive in collaborative environments. You exhibit strong leadership skills and can effectively manage cross-functional teams to drive quality improvements. Your ability to handle complex situations with calm and strategic problem-solving makes you an invaluable asset to the team.
Required Skills:
Bachelor’s degree and at least 7 years of experience in medical device quality systems, with at least 3 years of experience with Class III implantable medical devices.
Extensive knowledge of FDA QMSR, ISO 13485, and EU MDR regulations.
Strong leadership and project management skills.
Experience with supplier management and audit processes.
Proven track record of driving continuous improvement in quality systems.
Excellent communication and interpersonal abilities.
Preferred Skills:
Advanced degree.
Job Level: Management
Additional Information
The base compensation range for this role is: $131,000.00-$175,000.00
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being