Quality Systems 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 temporary, full-time Quality Systems Specialist on an 8-month contract, working on a hybrid model out of Richmond Hill, Ontario. The position entails the following:
PURPOSE AND SCOPE:
Supports 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.

Executes established processes in support FMCC’s quality system and generates and maintains associated documentation for the Canadian Head Office and distribution centres.

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. Supports the development, implementation, and maintenance of FMCC’s QMS maximizing harmonization with U.S. and European parent company quality systems.

2. Works with initiators of quality exceptions, nonconformances and CAPAs across all FMCC Departments to collect information, investigate, determine root cause(s) and implement corrections/corrective actions within established timelines.

3. With guidance from the quality system supervisor, reviews new documents, as well as changes to existing documents, to ensure enhanced quality and productivity, while maintaining compliance with global corporate and regulatory authority requirements.

4. Other duties as assigned.

PHYSICAL DEMANDS AND WORKING CONDITIONS:
Typical office work environment with occasional lifting (documents or samples) less than 10Kg. Occasional travel (typically less than 10 days per year) may be necessary to attend conferences, training or participate in audit activities.

EDUCATION:

- University degree in a science related to the work being carried out is preferred, a college diploma and practical experience in the responsibility area will be considered.
- Quality Assurance or System post graduate diploma is preferred.

EXPERIENCE AND REQUIRED SKILLS:

- 1-3 years of QS experience with background in GMP/QSR and Health Canada and/or FDA regulations.

▪ Strong experience with the management of compliance exception reporting (CAPA, non-conformance reporting, supplier corrective activities, etc).

▪ Experience with QMS Trackwise software (QTrak) is preferred.

▪ Excellent verbal and written communication skills are required. Writing investigation report for CAPAs are a job expectation.

▪ Strong interpersonal, team facilitation, and communication skills; as well as the ability to work effectively in cross-functional and geographically diverse communities.

▪ Strong organizational, analytical, and problem-solving skills.

RELATIONSHIPS:
Internal Contacts: All Fresenius Medical Care Canada departments with respect to their function within the QMS.

External Contacts: Fresenius Medical Care quality and manufacturing contacts in the USA, Mexico and Europe, vendors and occasionally FMCC customers.

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.

Thank you for your interest in Fresenius Medical Care Canada. We thank all interested applicants, however, only those selected for an interview will b