Bilingual QA Associate / Associé bilingue, Assurance qualité

Medline; Terrebonne; On-site; CAD 50,000 - 80,000; Full time

Job summary

An established industry player in healthcare is seeking a Bilingual QA Associate to join their team. This role involves ensuring regulatory compliance for products, managing customer complaints, and coordinating resolutions. You will log complaints, communicate with vendors, and prepare necessary reports for Health Canada. The ideal candidate will have a Bachelor’s degree in Science, experience in Quality Assurance, and be fluent in both French and English. Join a collaborative environment dedicated to improving lives and enjoy a competitive compensation package along with numerous employee benefits.

Benefits

Collaborative work environment

Market competitive compensation and benefits

Paid vacation and personal days

Career growth and training programs

Employee Assistance Program (EAP)

Fitness subsidy

Recognition programs

Social activities

Qualifications

• 1-3 years experience in Quality Assurance in Medical Device or Pharmaceutical GMP.
• Excellent communication skills in both French and English.

Responsibilities

• Assist in maintaining regulatory compliance for Medline products.
• Log and manage complaints in SAP, coordinating resolutions with vendors.
• Prepare and submit Medical Device Problem Reports to Health Canada.

Skills

Bilingual communication (French and English)

Problem-solving skills

Negotiation skills

Detail-oriented

Ability to manage multiple priorities

Education

Bachelor’s Degree in Science

Post Graduate certificate in Regulatory Affairs & Quality Assurance

Tools

Microsoft Office

SAP

AS400

Job description

Value Proposition

As a leading partner in healthcare, Medline Canada's sole purpose is Together Improving Lives – this means being deeply committed to the health and well-being of our customers, employees, partners and our communities. We employ a diverse group of top talent focused on growing and making a difference in the lives of Canadians, coast-to-coast.

Compensation is only one part of the Employee Value Proposition that Medline Canada offers our employees. As part of our mission, we offer one of the most competitive and engaging employee experience programs in Canada, which includes:

• Collaborative work environment with highly engaged employees
• Market competitive compensation and benefits plan, including LTD & Insurance
• DPSP match program
• Annual Employee Appreciation Week
• Paid vacation and personal days
• Lifeworks Employee Assistance Program (EAP) Resources supporting mental, physical, family and financial well-being
• Career growth and training programs
• Open communication with Senior Leaders
• Tailored incentives for eligible employee groups, such as home office reimbursement and Sylvan Learning Centre credit
• Employee referral program
• Education support programs
• Fitness subsidy
• Recognition programs
• Social activities
• And much more…

JOB SUMMARY

Reporting to Manager Quality Assurance, the Bilingual QA Associate is responsible for assisting in maintaining regulatory compliance of complaints for Medline branded and distributed products sold by Medline Canada.

CORE JOB RESPONSIBILITIES

• Log into SAP and acknowledge all French language complaints and assigned Medline divisions/ National Brand complaints (EN/FR) received from customers. Submit complaint information to the vendor in a timely manner. Also, coordinate customer resolution in the form of a return and credit/replacement.
• Maintenance of open complaints: coordinate return of products to the vendor for investigation; communication and follow-ups with the vendor to facilitate the completion of the investigation.
• Closure of complaints in SAP and submitting a final closing email or letter to the customer summarizing the complaint and investigation results.
• For reportable incidents, prepare and submit Medical Device Problem Reports or Adverse Reaction Reports to Health Canada as per required regulatory requirements and timelines.
• Request stock checks for complaints and track results.
• Assist with disposition of complaint-related quarantined product.
• Assist with product recall processing when requested– conduct stock checks for affected inventory, compile list of customers affected, prepare recall letters, and notify customers as well as Health Canada (when applicable).
• Assist Manager, Quality Assurance and Sr Dir., QARA with other duties as required.

QUALIFICATIONS

• Bachelor’s Degree or equivalent preferably in Science
• 1 to 3 years of experience in a Medical Device / ISO or Pharmaceutical GMP environment in Quality Assurance is preferred.
• In process of completing or completion of Post Graduate certificate in Regulatory Affairs & Quality Assurance from an accredited college is an asset.
• Excellent written and verbal communication skills in French and English.
• Ability to work effectively independently as well as in a team environment managing multiple priorities in a fast-paced environment.
• Detail oriented, highly organized, and problem solving skills
• Good negotiation skills
• Proficiency in computer skills (Microsoft Office, experience with SAP and AS400 is an asset).
• Available and comfortable to work in a warehouse environment when required.

English is required due to the scope of the role.

This job description is not intended to be all-inclusive. Employee may perform other related duties as required to meet the ongoing needs of the organization.

Medline Canada is proud to be an equal opportunity employer.