Job Overview
Location
Remote, USA
Job Type
Full-time
Category
Operations
Date Posted
April 22, 2026
Full Job Description
đź“‹ Description
- • 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, while managing quality procedures, electronic document control systems, audit programs, CAPAs, training programs, and document control.
- • You will lead regulatory, collaboration partner, and supplier audits, own and manage updates to quality documentation, drive continuous improvement initiatives, and schedule and lead supplier qualification activities in accordance with ISO 13485.
- • You will collaborate with cross-functional teams to foster a culture of quality, ensure seamless management of quality documentation and audits, and support device quality and compliance essential for product success and regulatory alignment.
🎯 Requirements
- • 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.
🏖️ 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
Skills & Technologies
About Biogen, Inc.
Biogen is an American biotechnology company that develops and manufactures therapies for neurological and neurodegenerative diseases. Founded in 1978, the company focuses on treatments for conditions such as multiple sclerosis, Alzheimer’s disease, spinal muscular atrophy, and amyotrophic lateral sclerosis (ALS). It also produces biosimilar drugs for immune and inflammatory diseases. Biogen operates globally with research, development, and manufacturing facilities supporting its mission to improve outcomes for patients with serious neurological disorders.
Subscribe to the weekly newsletter for similar remote roles and curated hiring updates.
Newsletter
Weekly remote jobs and featured talent.
No spam. Only curated remote roles and product updates. You can unsubscribe anytime.
Similar Opportunities
17 days ago
