Quality Complaints Specialist (Bilingual)

Fresenius Medical Care; Richmond Hill; On-site; CAD 55,000 - 75,000; Full time

Job summary

Fresenius Medical Care Canada is seeking an experienced complaints specialist to manage product complaints in a regulated environment. You will log and track cases, gather investigation data, and coordinate cross-functional communication with customers, vendors, and regulators.

The role requires a university degree in a science field, 3–5 years in a similar regulated setting, and strong English/French communication skills.

Qualifications

• 3-5 years experience in a similar role in a regulated environment.
• Excellent verbal and written communication skills are required.
• Bilingual (French and English).

Responsibilities

• Log complaints into Fresenius Medical Care manufacturers' electronic complaint management systems.
• Maintain local logs for complaints.
• Communicate with external customers to obtain additional information required for investigations.
• Follow up with vendors on the status of their complaint investigations.
• Prepare correspondence for communication with customers, regulatory agencies, vendors and other external parties.
• Coordinate return, reception, inspection and shipping of complaint samples for investigation.
• Prepare and distribute complaint/metric trending reports and present status at reviews.
• Participate on CAPA investigation teams and local product assessment committee as SME for complaints.
• Author and maintain SOPs related to complaint handling at FME Canada.
• Assist with quality assurance or quality system activities as needed.

Skills

MS Office

Verbal & written communication

Bilingual English/French

Attention to detail

Team player

Education

University degree in science

Tools

Qtrak

SmartSolve

Job description

PURPOSE AND SCOPE

Supports Fresenius Medical Care Canada (FME Canada)'s vision, core values and customer service philosophy. Adheres to the FME Canada and applicable Global Compliance and Quality Management System Programs, including following all regulatory and FME Canada policy requirements.

The primary function of this position is the timely completion of activities related to complaint handling, for products marketed in Canada.

DUTIES / ACTIVITIES

CUSTOMER SERVICE

• Responsible for driving the FME Canada 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

• Log complaints, into Fresenius Medical Care manufacturers' electronic complaint management systems.
• Maintain local logs for complaints.
• Communicate with external customers to obtain additional information required for investigation of complaints.
• Follow up with vendors on the status of their complaint investigations for products distributed by FME Canada.
• Prepare correspondence for communication with customers, regulatory agencies, vendors and other external parties.
• Coordinate return, reception, inspection and shipping of complaint samples to the manufacturers for further investigation.
• Preparation and distribution of complaint and metric trending reports and presentation of complaint process status at management reviews or upon request.
• Participate on CAPA investigation teams and local product assessment committee as the subject matter expert for complaints.
• Author and maintain SOPs related to complaint handling at FME Canada.
• On occasion, assist with quality assurance or quality system activities such as vendor management, internal audits or recall execution.
• Other duties as assigned by the Head of Quality.

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 with 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

• 3-5 years experience in a similar role in a regulated environment.
• Proficiency with MS Office tools is required and experience with Qtrak and/or SmartSolve complaint software is an asset.
• Excellent verbal and written communication skills are required.
• Bilingual (French and English).
• Strong interpersonal, team participation, and communication skills; as well as attention to detail are required.

RELATIONSHIPS

Internal Contacts: Customer Service, Warehouse, Technical Service, Post Market Vigilance, Marketing and Quality teammates.

External Contacts: Vendors, end users of FME Canada 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 performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position.