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Quality System Manager

Quality System Manager

R&D PartnersSan Carlos, CA, United States
3 days ago
Job type
  • Full-time
Job description

R&D Partners is seeking to hire a Manager, Quality Systems (contract) in San Carlos, CA.

Your main responsibilities as a Manager, Quality Systems (contract) :

  • Assist with development and maintenance of the company's Quality Management System (QMS) in accordance with company procedures and regulatory requirements (e.g., 21CFR Part 11).
  • Assist with driving continuous improvement initiatives that relate to QMS to enhance quality, efficiency, and compliance across all departments.
  • Collaborate cross-functionally with IT, and other departments to ensure alignment of quality objectives and initiatives.
  • Strive to foster a culture of quality and continuous improvement.
  • Assist with preparation for and participate in regulatory inspections and customer audits, ensuring readiness and compliance.
  • Ensure alignment with department management and company vision

What we are looking for in a Manager, Quality Systems (contract) :

  • Bachelor's degree in a relevant scientific discipline.
  • Minimum of 5 years of experience in quality management within a regulated industry (e.g., medical devices, pharmaceuticals, biotechnology).
  • Demonstrate knowledge of GXP regulations and guidelines as it pertains to Quality Systems.
  • Experience in assisting with the validation, implementation, and managing Quality Management Systems (QMS) compliant with FDA regulations (e.g., 21 CFR Part 820), and other relevant regulatory requirements.
  • Experience driving cross-functional collaboration
  • Why Choose R&D Partners?

    As an employee, you have access to a comprehensive benefits package including :

  • Medical insurance – PPO, HMO & HSA
  • Dental & Vision insurance
  • 401k plan
  • Employee Assistance Program
  • Long-term disability
  • Weekly payroll
  • Expense reimbursement
  • Online timecard approval
  • Pay Scale :

    $150,000 - $162,000 Dependent on Experience)

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    Quality Manager • San Carlos, CA, United States

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