Quality Assurance Specialist
7 months ago
Cardinal Health, with over 1300 employees in Canada, is an essential link in the Canadian healthcare supply chain, providing over 70,000 products to healthcare facilities and medical professionals across the country.
Cardinal Health is seeking a positive individual to join the Regulatory Affairs and Quality Assurance team as a Quality Assurance Specialist.
Cardinal Health Canada is currently seeking a Quality Assurance, Specialist
- Complaints to join the Quality Assurance Team.
For more information on what it is like to work for us, please watch this video:
This role is responsible for managing the customer product complaints, and maintaining regulatory compliance with regards to product complaints and vigilance reporting for all products manufactured by or distributed by Cardinal Health.
For more information on what it is like to work for us, please watch this video: Cardinal Health - Wings.
**_ Your Contributions to the Organization will be to_**:
- Manage product complaints in the complaint management systems for Cardinal Brand and supplier products in accordance with regulatory requirements and internal standard operating procedures
- Demonstrates a strong knowledge of the regulatory requirements
- Manage all complaint sample returns for all product types.
- Assess complaints for reportability to Heatlh Canada.
- Prepare, and submit preliminary and final Mandatory Problem Reports to HC within the required timelines.
- Interacts and successfully works with cross-functional departments to address complaint queries and resolve issues.
- Tracks customer complaints, maintain KPIs and report on complaint trends.
- Adheres to established policies and procedures
- Supports the following quality processes as required: Corrective Action/Preventive Action (CAPA), non-conformances, quality training, management review, document control, change management and control of records.
- Offer support for holds and recall processes as required.
**_ This Job might be for you if you have:_**
- Bachelor’s degree in relevant science discipline.
- 1-3 years’ experience in related field, preferred.
- Applied comprehensive knowledge of the Health Canada Food and Drug Act, Canadian Medical Devices Regulations, Drug Regulations and GMP, Natural Health Product Regulations, Cosmetics and Consumer Regulations.
- Highly organized, problem solving, analytical and focused;
- Proven communication skills (verbal, written and presentation skills).
- Bilingualism (French and English, spoken and written), preferred.
**_Cardinal Health is committed to accommodating applicants with disabilities throughout the hiring process, in accordance with the Accessibility for Ontarians with Disabilities Act (AODA). Our Human Resources team is responsible for working with applicants requesting an accommodation at any stage of the hiring process._**
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- Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law._
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