Product Complaint Specialist - United States
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Summary:The Product Complaint Specialist is a technical position that is responsible for receiving, documenting and coordinating complaint investigations of products according to FDA and European requirements for medical device complaints handling. This position interfaces with the Manufacturing Engineering, Service, and Technical Support groups as well as Site Management to support the resolution of complaint issues and initiation of corrective or preventive actions related to customer complaints and complaint product returns.
Duties and Responsibilities:
- Establish and maintain product complaint files for all customer complaints, according to US and International regulatory and compliance requirements.
- Review of all received product complaints to identify if a complaint is reportable under the Medical Device Reporting (MDR) requirements in the US or other international Vigilance system.
- Coordination with complaint investigation personnel to understand root cause analysis in support of documentation to properly close the complaint.
- Interact with other functional groups inside and outside the Quality department during complaint investigation and closure process.
- Maintenance of all complaint procedures, files and records according to established procedures
- Establish and maintain quality metrics for all product complaints, according to the direction of the Quality leadership.
- Oversee and coordinate the medical device product recall process, including recall reporting in the US, EU and Canada.
- Support the ongoing education/training of personnel involved in the complaint handling and investigation process.
- Support Continuous Improvement initiatives related to complaint handling.
- Perform other duties as assigned.
- Bachelor of Science degree from an accredited college or university in a technical discipline and 3-5 years of experience in the medical device industry related to product complaint handling and quality system activities.
Knowledge, Skills & Abilities:
- Working knowledge of Medical Device Complaint Regulations and Standards (FDA, ISO 13485, ISO 14971, MDD, IVDD)
- Proficient in root cause analysis and problem solving tools.
- Experience with scientific instrumentation in a design and manufacturing environment a plus
- Independent problem solving skills
- Computer proficiency with background in Agile and SAP business information systems a plus
- Energetic, results-driven with excellent organizational and prioritization skills.
- Excellent written and verbal communication skills and highly effective time management skills.
- Ability to operate independently and as part of a team
- Commitment to continuous improvement principles.