Job Description
An employer in the San Diego, CA area is looking for a REMOTE Quality Assurance Product Monitoring Specialist. This candidate will act as primary notification and consolidation point for receiving, processing, analyzing and reporting Medical Device product complaints. Maintains and analyzes reported events to identify and report recurring issues to quality assurance management and product development. Documents and tracks contact information, reported issues and problems in accordance with company guidelines and external regulatory requirements. They will directly answer telephone and written or Internet-based inquiries regarding company product complaints. They will work with the team to identify and supports the resolution of issues through the coordination of investigations, identification and escalation of adverse trends, and management of complaint and product performance processes. They will also evaluate complaints for reportability to government agencies (e.g. FDA, TGA, EU Competent Authorities, etc.) and ensures the timely submission of appropriate adverse event reports (i.e. MDRs and Vigilance Reports). Receives and assesses product complaints, and performs initiation, investigation, analysis, reporting, and closure of complaint records to ensure the program conforms to required regulations and standards. Ensures the product complaint monitoring process remains effective and compliant through participation in continuous improvement programs.
Required Skills & Experience
- Bachelor's Degree in a related field
- 2+ years of Complaints Experience doing intake and processing of complaints (logging, documenting, and supporting investigation which is done by the Engineers)
- Understanding of regulatory topics, including trends in the medical device industry pertaining to compliance.
- Proficient in Microsoft Word and Excel (Pivot Tables and VLOOKUPS).
- Data collection experience in a QMS System (ETQ, TrackWise, or SalesForce)
- Experience in responding to inquiries or complaints from customers, regulatory agencies, and members of the business community.
- Experience working under ISO 13485 and ISO 14971 regulations
Nice to Have Skills & Experience
- Bachelor's Degree in a Life Sciences related field (Kinesiology, Exercise sciences, Biology, Regulatory Sciences, etc.)
- Medical Device experience working with Implants, Surgical Medical Devices, Limb or Spine, or Orthopedic Medical devices
- Experience working on the ETQ - QMS System
Understanding of Medical Device regulatory requirements EX) 21 CFR 820, 21 CFR 803, 21 CFR 1271
- EU regulations (MDD 93/42/EEC, MDR 2017/745), SOR/98-282 and TGA Medical Device Regulations.
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.