Medical Device Complaint Specialist

1 month ago


San Diego, California, United States MML US, Inc. Full time
Mainstay Medical: A Leader in Medical Device Innovation

Mainstay Medical is a pioneering medical device company dedicated to developing innovative solutions for people with chronic mechanical Low Back Pain. Our flagship product, ReActiv8, is a neurostimulation system designed to improve the quality of life for those affected by this debilitating condition.

The Role: Associate Quality Assurance Specialist

We are seeking an experienced Associate Quality Assurance Specialist to join our team in the United States. As a key member of our Quality department, you will play a critical role in ensuring the highest standards of quality and compliance in our products.

Key Responsibilities:
  • Identify, review, and process complaints for evaluation in accordance with applicable regulations and company procedures.
  • Communicate and collaborate with Therapy Managers, Quality Compliance Experts, Product Safety Risk Managers, Product Engineers, and business representatives to ensure effective complaint investigations.
  • Communicate adverse events and reportable incidents to Quality Compliance Experts.
  • Assist in providing information needed in response to regulators and competent authority inquiries.
  • Perform data analysis to ensure business and quality requirements are met.
  • Support internal and external audits as needed.
Qualifications:
  • Bachelor's degree (or equivalent work experience) with a minimum 2 years of related experience in the medical device industry.
  • Experience with complaint handling and vigilance reporting.
  • Experience working in an FDA and/or ISO 13485 regulated industry.
  • Experience reviewing design history records (DHR).
  • Excellent communication, documentation, and time management skills.
  • Critical thinking skills and great attention to detail.
  • Experience using the Grand Avenue Software Complaint Handling Module.

Mainstay Medical offers a competitive hourly rate of $32.00 to $35.00/hour, as well as a comprehensive benefits package and equity opportunities. We are an Equal Opportunity Employer and welcome applications from qualified candidates without regard to gender, race, color, religious creed, national origin, age, sexual orientation, gender identity, physical or mental disability, and/or protected veteran status. Mainstay Medical participates in E-Verify.



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