SUMMARY
This position is responsible for complaint and regulatory reporting system activities including logging, investigation and closure of complaints. Additional responsibilities including assisting with responding to regulatory inquiries on complaints.
PRIMARY RESPONSIBILITIES
Manage complaint files, including opening files, evaluating complaints for complaint reportability in the US and worldwide, and preparing files for closure.
Perform device failure investigations independently and as part of a team.
Perform root cause analysis and identify improvement opportunities.
Report weekly and monthly on complaint summaries and metrics.
Follow up with in-house personnel regarding complaint investigation outcomes.
Assist with responses to regulatory inquiries.
ADDITIONAL RESPONSIBILITIES
Provide support for internal, FDA, Notified Body and other audits.
Communicate with internal personnel regarding product issues.
Perform other tasks related to the company’s Quality Management System.
KNOWLEDGE, YEARS OF EXPERIENCE AND EDUCATION
3-5 years in the medical device industry
Some experience handling and investigating complaints preferred
Proficient in MS Office tools
Strong critical thinking skills to evaluate and investigate customer complaints
Effective verbal and written communication skills
Associates Degree or higher in Science or related field prefered
Maintain strong attention to detail, especially during times of increased workload
Working knowledge of ISO 13485: 2003, 21 CFR 820
