Cardinal Health Quality Assurance, Specialist - Complaints in Vipond, Canada

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:

http://tinyurl.com/yck9koo2

Position Summary

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.

Key Responsibilities

  • 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.
  • Other duties and responsibilities as required. Experience.

  • University degree in a relevant Science discipline.

  • Minimum of 2-5 years experience in a Quality role within the medical device or pharmaceutical industry (distribution or manufacturing).
  • 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);
  • Demonstrates detail-oriented attention in all facets of responsibilities.
  • Bilingual

Cardinal Health is committed to employment equity and encourages applications from women, visible minorities, Aboriginal peoples and persons with disabilities. 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.

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.