- Assures that complaint management, including appropriate response to risks, adverse event reporting decisions, and collection and documentation of complaints data represents the maximum quality and reliability attainable.
- Assures that timely responses regarding product complaints are provided to customers and Regulatory Authorities.
- Actively contribute to making better products, and bolstering positive relationships with Regulatory Authorities.
- Receive, document, and respond to Smiths Medical product complaints according to global regulatory requirements, and Smith Medical SOPs:
- Process product complaint samples for investigation.
- Maintain complaint records.
- Coordinate internal complaint investigations to ensure completion in a timely manner.
- Use judgment to analyze adverse incidents, and determine if events must be reported to Regulatory Authorities.
- Communicate with customers to gain information for complaint investigation and to convey investigation results.
- Provide active support for the product complaints phone line, Product Complaints Lab, and global complaints email inbox.
- Support Smiths Medical sites in internal and external audits, as they relate to global product complaints.
- Remain current on Smiths Medical product-related issues and trends.
- Prepare reports and make recommendations regarding adverse complaint trends, the results of complaint investigations, and problem solving activities.
- Actively engage in providing input on process improvements.
- Escalate relevant product complaint issues through the Complaints Management team and the appropriate Quality Systems managers, and management, as necessary.
- Other duties as assigned, according to the changing needs of the business.
Position Description & Requirements:
This position is required
to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including but not limited to FDA, Quality Systems Regulations, ISO 13485, ISO 14001, government occupational health and environmental regulations and statutes).
Technical Knowledge and Skills:
- BS/BA degree strongly preferred.
- Ability to use standard office equipment such as, but not limited to, photocopier, fax, scanner, telephone, and headset.
- Knowledge of and expertise in the use of personal computers for spreadsheets (Excel), communication and scheduling (Outlook), word processing (Word), data entry (Pilgrim SmartComplaints), and various databases (Oracle, SharePoint).
- Prefer at least 1 year experience working with product complaints in a medical device company or legal experience with medical claims or equivalent.
Smiths Medical - 23 months ago
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