Senior Manager, Device Quality Systems

Biogen

Base: $131,000.00-$175,000.00; bonus/equity: short...
Not specified (assumed to be hybrid based on typical industry standards).
7 years medical device quality experience
Class iii implantable device knowledge
Fda qmsr and iso 13485 expertise
Biogen is seeking a Senior Manager of Device Quality Systems to ensure regulatory compliance and uphold quality standards for Class III medical devices. The role involves leading quality system activities, managing audits, and fostering a culture of quality within the organization

Job Summary

  • This role is pivotal to ensuring regulatory compliance and upholding quality standards across the lifecycle of Class III medical devices.
  • The position involves leading regulatory, collaboration partner, and supplier audits to ensure strict adherence to quality and regulatory standards.
  • Employees are eligible for a competitive benefits package including medical, dental, vision, life insurance, and up to $10,000 in tuition reimbursement.

Matching Summary

Match Score: 85

Biogen is seeking a Senior Manager of Device Quality Systems to ensure regulatory compliance and uphold quality standards for Class III medical devices. The role involves leading quality system activities, managing audits, and fostering a culture of quality within the organization.

Salary

Base: $131,000.00-$175,000.00; Bonus/Equity: Short-term cash bonus and equity incentive opportunities; Benefits: Medical, Dental, Vision, Life, 401(k) match, Tuition reimbursement

Skills & Requirements

Must-have

  • 7 years medical device quality experience
  • Class III implantable device knowledge
  • FDA QMSR and ISO 13485 expertise
  • Supplier audit and qualification management
  • Cross-functional team leadership

Nice-to-have

  • Passion for maintaining high-quality standards
  • Strategic problem-solving abilities
  • Advanced degree in relevant field
  • Strong communication skills
  • Commitment to continuous improvement

Key Requirements

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

Work Rights

Not specified

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