Sr. Design Quality Systems Manager

BDX

San Diego, CA, US
Base: $158,300.00 - $261,100.00 usd annual; bonus/...
Fully remote
Design control requirements application
Quality management system compliance
Capa process management
The Sr Design Quality Systems Manager is responsible for ensuring consistent application of Design Control requirements and best practices at the San Diego Design Center

Job Summary

  • The Sr Design Quality Systems Manager is responsible for ensuring consistent application of Design Control requirements and best practices at the San Diego Design Center.
  • At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry.
  • A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work.

Matching Summary

The Sr Design Quality Systems Manager is responsible for ensuring consistent application of Design Control requirements and best practices at the San Diego Design Center.

Salary

Base: $158,300.00 - $261,100.00 USD Annual; Bonus/Equity: Not specified; Benefits: Competitive compensation and benefits programs

Skills & Requirements

Must-have

  • Design Control requirements application
  • Quality Management System compliance
  • CAPA process management
  • Risk Management system oversight
  • Internal and external audit coordination
  • Medical device regulatory expertise
  • Quality system auditing

Nice-to-have

  • Cross functional team collaboration
  • Critical thinking and analytical skills
  • Assertiveness and communication skills
  • Leadership in multi-disciplinary projects
  • Experience working in a design center

Key Requirements

  • Bachelor's Degree in engineering or life sciences
  • Minimum 10 years in Quality Assurance in FDA regulated industry
  • Minimum 3 years management experience of QA staff
  • Certified Engineer or Auditor by ASQ (preferred)
  • Green Belt or Black Belt certification (preferred)
  • Expertise in medical device CAPA process
  • Experience managing regulatory audits

Work Rights

Not specified

Tailored Resume

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