Director, Quality Assurance And Regulatory Affairs

Noah Medical

San Jose, California, US
Base: $201,000 - $251,000 usd; bonus/equity: not s...
On-site
Quality management system (qms)
Regulatory requirements
Product development stages
Establishes RA/QA department operational objectives/budgets, manages staff hiring, assignments, performance feedback, and coaching to support company milestones

Job Summary

  • Establishes RA/QA department operational objectives/budgets, manages staff hiring, assignments, performance feedback, and coaching to support company milestones.
  • Supports defining, training and implementing the quality management system (QMS) at Noah Medical and the ongoing maintenance of the QMS to ensure that the quality system is properly documented and revised as necessary to assure continued compliance with US and International regulatory requirements.
  • Noah Medical offers a comprehensive benefits package including: competitive pay, health insurance, 401K and stock purchase plans, tuition reimbursement, paid time off plus holidays, and a flexible approach to work with remote, hybrid, field or office work schedules.

Matching Summary

Establishes RA/QA department operational objectives/budgets, manages staff hiring, assignments, performance feedback, and coaching to support company milestones.

Salary

Base: $201,000 - $251,000 USD; Bonus/Equity: Not specified; Benefits: Comprehensive benefits package

Skills & Requirements

Must-have

  • Quality Management System (QMS)
  • regulatory requirements
  • product development stages
  • customer complaint management
  • internal and supplier audits

Nice-to-have

  • startup environment experience
  • sterile/disposable medical device knowledge
  • career growth motivation
  • team builder
  • excellent communication skills

Key Requirements

  • BS in Engineering or Technology
  • 10+ years RA/QA medical device experience
  • 3+ years supervisory experience
  • Experience implementing QMS for US FDA and ISO
  • Experience hosting 3rd party audits

Work Rights

Not specified

Tailored Resume

Cover Letter