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.
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.
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