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 System Specialist, on a 1-year contract covering a Maternity Leave, working out of our head office in 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. When needed, assists initiators of TDR, process, premise and quality system software change controls, project/quality plans, to ensure robust quality planning and executes related quality system activities within established systems.

4. 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.

5. Assists with the development, implementation, and maintenance of process characterization activities including process mapping, metric trending plans, exception response, risk assessment documentation, etc, maintaining communications in support of quality system activities such as various meetings, overall quality metrics, support of quality system processes and procedures, etc.

6. Prepares and distributes metrics and reports demonstrating the QMS performance related to training, NC, CAPA, Change Control, TDR, Supplier management and other quality systems as required.

7. Collects supplier data necessary for assessments including questionnaires, evidence of qualification, and performance data.

8. Conducts audits to GMP and ISO 13485 requirements for both internal and external parties, generates audit reports and follows up on resulting nonconformances to closure.

9. 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.
- Training / Certification in Quality Systems auditing is an asset (i.e. ISO lead auditor; ASQ CQA, RAB)
- L6 sigma green belt or project management certification is an asset.

EXPERIENCE AND REQUIRED SKILLS:

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

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