Job Overview
Location
Remote, USA
Job Type
Full-time
Category
Operations
Date Posted
April 22, 2026
Full Job Description
đź“‹ Description
- • As the Manager, Quality Systems within the Device Quality team at Biogen, you will be pivotal in ensuring regulatory compliance and supporting quality across the lifecycle of Class III medical devices, directly contributing to patient safety and product integrity.
- • You will develop, implement, and execute quality system activities aligned with FDA QMSR, ISO 13485, EU MDD, and EU MDR; maintain the Implantable Device Unit QMS; lead supplier audits; drive continuous improvement; and ensure training and SOP compliance.
- • You will join Biogen’s Device Quality team, reporting to the Head of Device Regulatory Affairs, Quality, and Compliance, collaborating cross-functionally to uphold the highest standards in medical device innovation and lifecycle management.
- • In this role, you will deepen your expertise in global medical device regulations, lead quality system enhancements, and make a tangible impact on the safety and compliance of life-changing implantable therapies.
🎯 Requirements
- • Bachelor’s degree in a relevant field and at least 5 years of experience in medical device quality systems, with minimum 2 years focused on Class III implantable medical devices.
- • Comprehensive knowledge of FDA Quality Management System Regulation (QMSR), ISO 13485, EU Medical Device Directive (MDD), and EU Medical Device Regulation (MDR).
- • Proven experience conducting audits, managing supplier qualifications, and leading cross-functional CAPA activities.
- • Familiarity with electronic document control systems and a track record of driving continuous improvement initiatives.
- • Excellent communication, organizational, and analytical skills with a detail-oriented, proactive mindset.
🏖️ Benefits
- • Medical, dental, vision, and life insurance coverage.
- • Fitness and wellness programs, including fitness reimbursement.
- • Generous time off: minimum 15 days paid vacation, end-of-year shutdown (Dec 26–Dec 31), up to 12 company-paid holidays, plus 3 personal significance days, and 80 sick hours annually.
- • Paid maternity and parental leave, 401(k) with company match, employee stock purchase plan, and tuition reimbursement up to $10,000 per year.
- • Access to Employee Resource Groups and a culture focused on inclusion, belonging, and innovation.
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.
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