Quality Complaints Specialist

Fresenius Medical Care is the world's largest integrated provider of dialysis products and services. As a vertically integrated company, we provide a complete solution for patients with chronic kidney failure and their caregivers, from research and development to manufacturing our dialysis products to providing complete therapy options within our own clinics. Fresenius Medical Care provides dialysis services in over 120 countries, including over 3400 dialysis clinics and 40 production sites worldwide.

In Canada, Fresenius Medical Care has been caring for patients undergoing dialysis for over twenty-five years. We understand the impact that chronic kidney failure has on people's lives, and we are committed to providing outstanding patient care that goes beyond innovative dialysis products and therapies. We care about each patient’s individual situation, whether they want to perform dialysis in their familiar surroundings at home, undergo dialysis at the hospital, or receive dialysis in one of our clinics. Our vision is to be the undisputed leader and trusted partner in renal therapies in Canada, and this vision is reflected in our key values: collaborative, proactive, reliable, and excellent.

Fresenius Medical Care Canada is currently recruiting for a permanent, full-time, Complaints Specialist, working out of our head office in Richmond Hill, Ontario. The position entails the following:
PURPOSE AND SCOPE: Supports Fresenius Medical Care Canada (FMCC)’s vision, core values and customer service philosophy. Adheres to the FMCC Compliance and Quality Management System Programs, including following all regulatory and FMCC policy requirements. The primary function of this position is the timely completion of activities related to complaint handling, postmarket surveillance and incident reporting to regulatory authorities for products marketed in Canada.

DUTIES / ACTIVITIES:
CUSTOMER SERVICE:

- Responsible for driving the FMCC culture through values and customer service standards.
- Accountable for outstanding customer service to all external and internal customers.
- Develops and maintains effective relationships through effective and timely communication.
- Takes initiative and action to respond, resolve and follow up regarding customer service issues with all customers in a timely manner.

PRINCIPAL RESPONSIBILITIES AND DUTIES:
1. Logging complaints and adverse drug events/reactions (ADE/ADRs), into FMC manufactures’ electronic complaint management systems. Maintaining local logs for complaints and ADE/ADRs.

2. Serve as the post market vigilance responsible person (PVRP) delegate for distributed FMC drug products as required.

3. Communicate with external customers to obtain additional information required for investigation of complaints. Follow up with vendors on the status of their investigation of complaints reported about their products distributed by FMCC.

4. Prepare correspondence for communication with customers, regulatory agencies, vendors and other external parties.

5. Coordinate return, reception, inspection and shipping of complaint samples to the manufacturer for further investigation.

6. Preparation and distribution of complaint and metric trending reports and presentation of complaint process status at management reviews.

8. Author and maintain SOPs related to complaint handling and incident reporting at FMCC.

9. On occasion, assist with quality assurance or quality system activities such as vendor management, internal audits or recall execution.

10. Other duties as assigned by the director

PHYSICAL DEMANDS AND WORKING CONDITIONS: Typical office work environment with occasional lifting (documents or samples) less than 10Kg. Handling of complaint return samples must be done in accordance to established health and safety procedures and using appropriate personal protective equipment.

EDUCATION:

- University degree in a science related field (chemistry, biology, biochemical engineering) is preferred, a college diploma and practical experience in the responsibility area will be considered.

EXPERIENCE AND REQUIRED SKILLS:

- 1-3 years experience in a similar role in a regulated environment.
- Proficiency with MS Office tools is required and experience with Qtrak and/or ArisG software is an asset.
- Excellent verbal and written communication skills are required.
- Strong interpersonal, team participation, and communication skills; as well as attention to detail are required.

RELATIONSHIPS: Internal Contacts: Customer Service, Warehouse, Marketing and QARA teammates. External Contacts: Vendors, end users of FMCC distributed products such as nurses, technicians, physicians, hospital risk management personnel and occasionally patients. Quality contacts at manufacturers with respect to follow up of ongoing investigations and complaint trend analysis.

SUPERVISION: N/A

The duties listed in this job description are intended only as illustrations of the various types of work that may be