About the job
General Purpose: The Quality Complaint Specialist is pivotal in supporting and conducting thorough investigations related to complaints about medical or pharmaceutical products. This role encompasses managing, documenting, and reporting quality events while ensuring adherence to regulatory standards, promoting continuous improvement, and achieving excellence in service. Collaboration with internal and external teams in an inclusive environment is essential.
Main Responsibilities:
- Conduct in-depth investigations, analyses, and follow-ups on product complaints, including functional, visual, or dimensional testing as necessary.
- Meticulously document all pertinent information (product history, device records, risk documentation, labeling) while ensuring compliance with laboratory, manufacturing, and documentation best practices.
- Identify the root cause of complaints and perform basic statistical analyses, reporting findings to relevant teams.
- Recognize potentially reportable events and escalate appropriately to the PMS Manager, Clinical Specialist, or regulatory authorities.
- Assist in managing CAPAs, NCEPs, OOTs, and other initiatives aimed at improvement and compliance.
- Engage in continuous improvement and innovation projects focused on the complaint investigation processes.
- Utilize documentation systems (QMS, databases, tracking sheets) for monitoring, tracking, and reporting outcomes.
- Provide training to peers on processes and products when necessary.
- Collaborate effectively in product integration and transfers between sites.
- Support environmental health and safety (EHS) initiatives, ensuring proper calibration, preventive maintenance, and control of laboratory equipment.
- Ensure prompt and effective closure of complaint investigations.
- Facilitate communication with third parties, including OEMs, Contract Manufacturers, internal clients, and functional areas.