Recalls & CAPA Manager

Noah Medical
San Jose, CA
Job Description
Noah Medical is building the future of medical robotics. We are looking for exceptional engineers and key team members to join our Quality team, where you'll play a pivotal role in driving innovation and product leadership in medical robotics.

Requirements

  • Bachelor's degree in an engineering discipline; advanced degree preferred.
  • Minimum of 7 years of RA/QA related experience in the medical device field (experience in capital equipment and services a plus)
  • In-depth knowledge of regulatory requirements, standards, and guidelines (e.g., FDA, CFDA, EU MDR, EMA, ISO).
  • Strong understanding of quality management systems, including GMP, GCP, and ISO standards, e.g. 13485.
  • Experienced in conducting internal audits and hosting 3rd party audits.
  • Good understanding of the medical device design, manufacturing, and field service processes
  • Self-starter, team builder, and excellent in verbal and written communication.

Benefits

  • Competitive Salary
  • Comprehensive health insurance including Medical, Dental and Vision + HSA and FSA options
  • Equity & Bonus Program
  • Life Insurance (company paid & supplemental) and Disability insurance
  • Mental health support through medical insurance programs
  • Legal and Pet Insurance
  • 12+ paid holidays, 15-20 days of PTO + sick time
  • Paid parental leave
  • In-office snacks and beverages
  • In-office lunch stipend
  • Learning & Development Opportunities: On-demand online training and book reimbursement
  • Team building and company organized social and celebration events
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