Complaints Officer

**Caring for Life. Make a difference. Be the difference.**

If you are looking to work for a growing, global corporation that is focused on making meaningful improvements in the safety, affordability, and availability of the care medical professionals provide to their patients, then you should consider Fresenius Kabi.

We are an employer that works to build great leaders, teams and businesses. We know our employees are key to everything we accomplish, so we give them the freedom and resources to reach their potential and the opportunity to work with managers who care about their professional development. We value integrity, encourage collaboration, celebrate passion, reward creativity, and demand excellence — because our customers deserve nothing less and our customers are at the heart of every one of our goals.

As a part of Fresenius Kabi, you can enjoy an exciting career, a company culture based on a clear purpose and values, and the knowledge that your work makes a real difference. If you would like to learn more about us, we would love to hear from you.

This is an exciting opportunity to join our Quality team as a **Complaints Officer** - there are currently two positions available:

- 1 Full-time, permanent
- 1 Full-time, temporary (contract for 12 months)

**_
THE IMPACT YOU WILL MAKE:_**

The Complaints Officer is responsible for managing product complaints received concerning the company drug products and medical devices using global Complaint Management Workflow (gCMW) and TrackWise systems. The Complaints Officer documents complaints and manages the complaint process as well as communicates with the National Safety Officer/Deputy 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.

**_ WHAT YOU’LL BRING:_**

**_ Knowledge & Education_**.** You have a Bachelor of Science Degree in chemistry and/or microbiology. Bilingualism in French is an asset.

**_ Experience & Skills_**.** You have three to five years of relevant experience in handling QA compliance based activities and are capable of writing technical reports. You also possess in-depth knowledge of GMP and GLP along with testing technologies in chemistry and microbiology. You are experienced in Canadian Medical Devices Regulations SOR/98-282 and ISO 9001/13485 standards.

**_ Attitude & Passion_**.** You are self-motivated and able to work productively with mínimal supervision. You have proven your ability to adhere to standards and procedures and maintain continuous confidentiality. You are passionate about process improvement and making suggestions to drive change.

**_ Technical Experience_**.** You are proficient in Microsoft® Office, PowerPoint and Excel (charting and spreadsheets expertise is required). Knowledge of SAP is an asset.Your critical thinking and decision-making skills are above average, and you demonstrate excellent analytical skills and high level of accuracy.

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WHAT WE’LL BRING:_**

**_ Exposure_**.** The hands-on experience and exposure to a global organization, combined with the mentorship of a dynamic and knowledgeable Quality team. You will be an integral part of reviewing SOP’s and processes to drive efficiency.

**_ Impact._** Direct influence on patient care by ensuring the safety and quality of our products in the Canadian market.

**_ Positive Collaborative Environment_**.** A welcoming, fun and energetic team environment that encourages open communication and collaboration. Our culture encourages our employees to hone current skills and build new capabilities, while discovering their genius.

Fresenius Kabi Canada is responsible for ensuring we can provide critical and lifesaving medical products and services to vulnerable members of our communities. We are committed to fostering a caring culture, a safe environment, and a healthy workplace for all employees. Everyone must follow safe work practices and comply with our health and safety policies, vaccination policy and Covid-19 protocols.
- The company is committed to meeting the accessibility needs of people with disabilities. Fresenius Kabi Canada is dedicated to breaking down barriers to accessibility, preventing new barriers from arising and to meet the accessibility requirements prescribed by the Accessibility for Ontarians with Disabilities Act (AODA). If you require accommodation at any time please contact us._

Fresenius Kabi Canada is an Equal Opportunity Employer