At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer, and more fulfilling. We are passionate about the medical technologies and solutions that we bring to the world that help detect and treat disease. We are invested in great ideas that serve you and the vibrant communities around us.
The position is responsible for owning and monitoring low-risk complaints from start to end per the complaint handling procedures, including communications with internal cross-functional partners (Triage, Investigators, MDR/Vigilance.).
- Accountable for managing thorough and accurate complaint records, as well as timely closure of complaint files
- Interfaces with Original Equipment Manufacturer (OEM) or Contractual Manufacturing as applicable
- Creates and communicates customer letters
- Ensure complaint records and applicable complaint handling documents are compliant with Good Documentation Practices (GDP)
- Maintain accurate and current training records at all times
- Re-opens complaint if required
- Minimum of a Bachelor’s degree.
- Must be able to maintain good attendance at regularly scheduled hours.
- Must be able to follow standard practices and procedures.
- Attention to detail and accuracy are required.
- Must be able to prioritize to meet regulatory/ procedural deadlines.
- Knowledge of Medical Device Quality Systems regulations, including ISO 13485, 21CFR820, and 21CFR803 (or other local and regional regulation requirements).
- Applies professional concepts and company policies and procedures, analyzes data or situations, and exercises judgment to recommend solutions to solve problems.
- Follows standard practices and procedures in analyzing situations or data from which answers can be obtained.
- Minimum of 1-year related experience preferred.
- Basic knowledge of medical terminology and human anatomy desired
- Hands-on experience in medical device complaint handling preferred.
- Familiarity with medical device terminology as well as anatomical and physiological terminology.
- Strong proficiency in typical computer applications such as Microsoft Office (Excel, Word, and Outlook).
- Excellent written and verbal communication skills.
- Critical thinking and good time management skills.
This is a full-time position, with an annual salary of $61,067 – $82,440.