As a global healthcare company, Fresenius Kabi is Committed to Life. The company’s products, technologies, and services are used for the therapy and care of critically and chronically ill patients. With more than 41,000 employees and presence in over 100 countries, Fresenius Kabi’s expansive product portfolio focuses on providing access to high-quality and lifesaving medicines and technologies.

POSITION SUMMARY

The Complaints Officer is responsible for managing incoming complaints associated with Fresenius Kabi Canada (the Company) drug products and medical devices using Global Complaint Management Workflow (gCMW) and/or KabiTrack electronic quality management systems.
The Complaints Officer documents complaints and manages the complaint process as well as communicates with the National Safety Officer, the fabricator, and the customer to ensure complaints are tested, investigated and responded to in a timely and appropriate manner. The Complaints Officer ensures that the complaint system is in compliance with Health Canada, Health Product and Food Branch Inspectorate Good Manufacturing Practice (GMP) guidelines, Canadian Medical Devices Regulations SOR/98-282 and ISO 9001/13485 standards.

QUALIFICATIONS

• Minimum Bachelor of Science degree in a Life Science, chemistry and/or microbiology preferred
• 3-5 years of relevant experience in handling QA compliance-based activities is required
• In-depth knowledge of GMP and GLP along with testing technologies in chemistry and microbiology is required
• In-depth knowledge of Biologics and Generic Therapies Directorate and Medical Devices Directive regulations is required
• Prior experience in the healthcare or pharmaceutical/medical device industry is preferred
• Experience in ISO 9001 and ISO 13485 standards and SAP system is an asset
• Experience in managing medical device compliance responsibilities
• Bilingual (English/French) is preferred

SKILLS

• Excellent communication skills (written and verbal)
• Excellent customer service skills and the ability to collaborate with all levels both inside and outside the organization
• Strong computer skills in Microsoft Office. Proficient in word processing, charting and spreadsheets
• Self-motivated and able to work with minimal supervision
• Strong attention to detail with the ability to multitask and handle fluctuating workloads
• Excellent organizational and problem-solving skills
• Excellent continuous improvement skills
• Proven ability to adhere to standards and procedures and maintain confidentiality
• Must be capable of writing technical reports
• Excellent analytical skills with attention to detail and high level of accuracy
• Results oriented
• Professional demeanor
• Ability to prioritize efficiently

MORE ABOUT US!

As ONE team, the companies in the Fresenius Group are committed to providing lifesaving and life-changing healthcare solutions on a global scale.
In Biopharma, Fresenius Kabi offers cutting-edge biosimilars for autoimmune diseases and oncology. With leading market positions in Clinical Nutrition, a broad portfolio of enteral and parenteral products makes a distinct difference in patients’ nutritional status. In MedTech, the company provides vital infusion pumps, cell and gene therapy devices, disposables, and more. Fresenius Kabi is the global leader in supplying blood collection bags and devices, supporting blood banks and healthcare facilities worldwide. The company’s I.V. Generics and Fluids for infusion therapy help save millions of lives every year, in emergency medicine, surgery, oncology, and intensive care.
Fresenius Kabi takes a holistic approach to healthcare and uniquely combines experience, expertise, innovation, and dedication – making a difference in the lives of almost 450 million patients annually.