Principal Specialist, Corporate Clinical Quality Assurance

The Corporate Clinical Quality Assurance (CQA) Principal Specialist will manage Corporate CQA activities in alignment with the strategies and goals set by Quality and Clinical leadership. This role plays a key part in ensuring the effectiveness of clinical quality systems and compliance with global regulatory standards through process improvement, oversight, and strategic collaboration.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, or a related field
• Minimum of 8 years' experience in Clinical Quality Systems, Clinical Operations/Project Management, or Regulatory Affairs
• Medical device industry experience required
• Extensive knowledge of FDA, ISO, EU MDR, and medical device quality requirements governing human subject research

Benefits

• Annual bonus target
• Long-term incentives
• Life insurance
• Disability insurance
• Flexible spending accounts
• Employee assistance program
• Paid time off
• Retirement savings plan
• Employee stock purchase plan