Manager, Device Quality Systems

Biogen

About The Position

As the Manager, Quality Systems within the Device Quality team, you will be pivotal in ensuring regulatory compliance and supporting quality across the lifecycle of Class III medical devices. This role involves developing, implementing, and executing quality system activities aligned with FDA Quality Management System Regulation (QMSR), ISO 13485, EU Medical Device Directive (MDD), and EU Medical Device Regulation (MDR). You will maintain the Implantable Device Unit Quality Management System (QMS) and foster a culture of quality in the development and lifecycle management of compliant Class III medical devices. Reporting to the Head of Device Regulatory Affairs, Quality, and Compliance, you will collaborate with various teams to ensure the highest standards of quality and regulatory adherence are met. This role is integral to advancing Biogen's commitment to quality and safety in medical device innovation and lifecycle management.

Requirements

Bachelor’s degree in relevant field and at least 5 years of experience in medical device quality systems, with at least 2 years of experience with Class III implantable medical devices.
Comprehensive knowledge of FDA QMSR, ISO 13485, EU MDD, and EU MDR.
Strong understanding of quality management systems and regulatory requirements.
Experience in conducting audits and managing supplier qualifications.
Experience in leading cross-functional CAPA activities.
Familiarity with electronic document control systems.
Proven track record in driving continuous improvement initiatives.
Excellent communication and organizational skills.

Nice To Haves

Advanced degree

Responsibilities

Support all aspects of the development and maintenance of the QMS for Class III medical devices, including quality procedures, audit programs, and document control.
Identify areas for improvement within quality systems and propose actionable solutions.
Lead supplier audits and support audits conducted by regulatory bodies and collaboration partners.
Provide quality documentation support to ensure compliance with QMS regulations.
Drive continuous improvement initiatives within the Implantable Device Unit product QMS.
Facilitate supplier qualification and ongoing management activities, ensuring compliance with ISO 13485 standards.
Ensure alignment of QMS processes with global regulatory requirements.
Assign and track required training, ensuring timely completion and accurate record maintenance.
Review new or revised Standard Operating Procedures (SOPs) for compliance and completeness.

Benefits

Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
Up to 12 company paid holidays + 3 paid days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10,000 per calendar year
Employee Resource Groups participation