Responsible for analyzing product complaints while maintaining the quality processes related to post-market product complaints to ensure compliance of all applicable Corporate and Divisional policies and procedures.
Ideal candidate will demonstrate thorough understanding of quality management standards as outlined in Good Manufacturing Practices (GMPs), FDA Code of Federal Regulations (CFRs) and ISO 13485. Actively participates in departmental process improvements and effectively communicates shared knowledge to contribute to overall company success.
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
- Performs accurate and timely data entry in corporate complaint database.
- Coordinates complaint investigations, including determining investigation strategies, as needed with internal and external resources.
- Communicates directly with customers regarding reported complaints and resolutions.
- Analyzes complaint data to identify any trends, and provides information to department management and other personnel that may lead to a Corrective Action Request.
- Works with other departments and vendors on known or emerging issues to resolve quality problems that may impact patient safety.
- Responds to technical or medical information requests from healthcare professionals, personnel and consumers.
- Assists global departments by providing ad-hoc reports related to product complaint trending and investigations.
- Cultivates a wide range of internal networks and begins to develop an external network of resources to facilitate completion of tasks.
- Plans, organizes, and prioritizes own daily work routine to meet established schedule.
- Exercises authority and judgment within defined limits to determine appropriate action. Recognizes that failure to achieve results or erroneous decisions or recommendations may result in significant non-compliance issues.
- Manages individual complaints on various product lines, from opening to closing.
Requirements:
- Minimum 2 years in medical device and / or pharmaceutical industry, preferably in a complaint handling position.
- Medical terminology/ophthalmic knowledge desired.
- Proficient computer skills in Excel and Word, with a good understanding of database management of complaint records.
- Prior experience using complaints processing software (such as CATSWeb) is desirable.
- Minimum 2 years in medical device and / or pharmaceutical industry, preferably in a complaint handling position.
- Medical terminology/ophthalmic knowledge desired.
- Proficient computer skills in Excel and Word, with a good understanding of database management of complaint records.
- Prior experience using complaints processing software (such as CATSWeb) is desirable.
Other Details:
