Senior Manager, Device Quality Systems

Biogen

Base: $131,000.00-$175,000.00; bonus/equity: short...
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Class iii implantable medical device experience
Fda qmsr and iso 13485 knowledge
Supplier audit and qualification management
** Biogen is seeking a Senior Manager of Quality Systems for its Implantable Device Unit to lead the development and execution of quality management initiatives for Class III medical devices, ensuring regulatory compliance and maintaining quality standards. The ideal candidate will have extensive experience in medical device quality systems, strong leadership skills, and a passion for quality assurance in a collaborative environment. **

Job Summary

  • This role is pivotal to ensuring regulatory compliance and upholding quality standards across the lifecycle of Class III medical devices within the Implantable Device Unit.
  • The position requires leading the development and maintenance of the Quality Management System while driving continuous improvement initiatives and managing complex supplier audits.
  • Biogen offers a competitive compensation package including short-term and long-term incentives, comprehensive health benefits, and a culture focused on delivering life-changing medicines.

Matching Summary

Match Score: 75

** Biogen is seeking a Senior Manager of Quality Systems for its Implantable Device Unit to lead the development and execution of quality management initiatives for Class III medical devices, ensuring regulatory compliance and maintaining quality standards. The ideal candidate will have extensive experience in medical device quality systems, strong leadership skills, and a passion for quality assurance in a collaborative environment. **

Salary

Base: $131,000.00-$175,000.00; Bonus/Equity: Short-term cash bonus and equity incentive opportunities available; Benefits: Medical, Dental, Vision, Life insurance, 401(k) match, tuition reimbursement up to $10,000

Skills & Requirements

Must-have

  • Class III implantable medical device experience
  • FDA QMSR and ISO 13485 knowledge
  • Supplier audit and qualification management
  • Cross-functional team leadership
  • Continuous improvement in quality systems

Nice-to-have

  • Strong strategic problem-solving skills
  • Passion for maintaining high-quality standards
  • Collaborative work environment preference
  • Detail-oriented approach to documentation

Key Requirements

  • Bachelor's degree required
  • 7+ years in medical device quality systems
  • 3+ years with Class III implantable devices
  • Extensive knowledge of EU MDR regulations

Work Rights

Not specified

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