Quality Complaint Specialist

Actalent•Santa Clara, CA

51d•$48 - $50•Onsite

About The Position

We are seeking a dedicated Quality Complaint Specialist to join our team. The role involves managing and investigating quality complaints, ensuring compliance with regulatory standards, and supporting continuous improvement initiatives. This position requires a strong understanding of complaint handling processes within the medical device or pharmaceutical industry.

Requirements

Bachelor's degree in a scientific or related field such as Chemistry, Biology, or Nursing.
2-3 years of experience in complaint handling, quality assurance, or regulatory affairs within the medical device or pharmaceutical industry.
Strong understanding of FDA regulations, ISO standards, and global complaint handling requirements.
Excellent written and verbal communication skills.
High attention to detail and strong organizational skills.
Proficiency in Microsoft Office and complaint management systems like TrackWise.
Ability to work independently and manage multiple priorities in a fast-paced environment.

Responsibilities

Conduct investigations into complaints, including root cause analysis and coordination with cross-functional teams such as R&D, Manufacturing, and Regulatory.
Determine regulatory reportability and submit Medical Device Reports (MDRs) to the appropriate agencies.
Maintain complaint records in accordance with internal procedures and regulatory standards.
Generate trend reports and metrics to identify recurring issues and support continuous improvement.
Participate in CAPA (Corrective and Preventive Action) activities related to complaint findings.
Support audit and inspection readiness by ensuring complaint files are complete and compliant.
Collaborate with IT and other departments to ensure complaint handling systems, such as TrackWise, are properly utilized.
Assist in the development of complaint closure letters and customer communications.