Clinical QA Specialist (Medical Devices)

Location: Newark, Delaware, United States, or Marlborough, Massachusetts, United States

Annual base salary: $85,200–$133,300, plus bonus eligibility.

Company

hirify.global develops medical technologies and products focused on improving healthcare and patient safety.

What you will do

• Investigate and assess potential and actual adverse events associated with medical devices.
• Prepare timely documentation, regulatory reports, and external notifications.
• Collaborate with Technical Service, Marketing, Sales, Regulatory, customers, patients, and regulatory agencies.
• Support and lead CAPAs, nonconformances, health risk assessments, and quality investigations.
• Develop metrics and quality reports for reportable events and identify potential excursions.
• Lead or participate in internal and external audits, inspections, and assessments.

Requirements

• Bachelor’s degree in Medicine, Nursing, Biomedical Engineering, Electromedical Engineering, or a related field; Risk Managers may also be considered.
• 5+ years of experience in a similar role, preferably in the medical device or healthcare industry.
• Hands-on experience with adverse event reporting, regulatory communications, and health risk assessments.
• Knowledge of FDA Quality System Regulations, ISO 13485, EU Medical Device Regulation, and ISO 14971 risk management.
• Experience supporting or leading CAPAs, nonconformances, and quality investigations.
• Strong analytical, organizational, communication, and regulatory compliance skills.

Culture & Benefits

• Fast-paced, collaborative, and cross-functional work environment.
• Comprehensive onboarding training and continued professional development throughout the career.
• Role is bonus eligible.
• Equal opportunity workplace inclusive of disability and veterans.