Senior Quality Systems Specialist

Nonin Medical
Minneapolis, MN
Category Engineering
Job Description
As a Senior Quality Systems Specialist, you will be responsible for ensuring the effective deployment and maintenance of a compliant Quality Management System (QMS), driving efficient quality processes across the organization, and collaborating with cross-functional teams to ensure alignment with business objectives and regulatory requirements.

Requirements

  • Bachelor's degree in Engineering, Science, Manufacturing, or related field
  • 5+ years of experience in Quality Systems, Quality Compliance, or Auditing within a highly regulated environment
  • Knowledge of FDA Quality System requirements, ISO 13485:2016, ISO 14971:2019, Medical Device Regulation, and Current Good Manufacturing Practices

Benefits

  • 401(k)
  • Tuition Reimbursement
  • Competitive Salary and Benefits Package
  • Medical, Dental & Vision coverage
  • Flexible Spending and Health Savings Accounts
  • Telemedicine Options
  • Mental Health and Fitness Offerings
  • Paid Time Off
  • Paid Holidays
  • Paid Parental Leave
  • Disability Insurance
  • Accident & Critical Illness Insurance
  • Life Insurance
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