SUMMARY

This position is responsible for complaint and regulatory reporting system activities including logging, investigating and closing complaints.  Additional responsibilities include 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 preferred

Maintain strong attention to detail, especially during times of increased workload

Working knowledge of ISO 13485: 2003, 21 CFR 820