About This Role:
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.
What You’ll Do:
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.
Who You Are:
You are detail-oriented and possess a strong analytical mindset that allows you to navigate complex regulatory landscapes effectively. Your proactive approach and commitment to quality ensure that compliance is not just a standard but a culture within your team. You thrive in collaborative environments, working seamlessly with regulatory affairs and quality compliance teams while maintaining a focus on continuous improvement. Your ability to communicate clearly and decisively empowers you to make informed decisions that drive quality systems forward.
Required Skills:
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.
Preferred Skills:
Advanced degree
Additional Information
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; including, but not limited to:
- 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
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
Top Skills
Biogen Cambridge, Massachusetts, USA Office
225 Binney Street, Cambridge, MA, United States, 02142
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