QA Specialist

Medline; Mississauga; On-site; CAD 60,000 - 80,000; Full time

Job summary

Medline Canada is seeking a QA Specialist to implement and maintain quality systems and documentation for their medical devices. This role involves creating device master records, vendor qualifications, and collaborating with suppliers to ensure product quality and compliance. Ideal candidates will hold a degree in Engineering or Science with relevant experience in a GMP/QMS environment.

Benefits

Competitive employee value proposition

Market competitive compensation and benefits plan

Career growth and training programs

Employee referral program

Recognition programs

Qualifications

• Minimum 2-3 years work experience with quality in a GMP/QMS manufacturing or distribution environment.
• Professional Quality Certifications such as ASQ an asset.
• Knowledge of GMP and QMS principles.

Responsibilities

• Create Device Master Records (DMRs) for Medline brand products.
• Initiate and lead vendor qualifications.
• Assist with complaint investigations to determine trends and lead corrective actions.

Education

Bachelor in Engineering or Science

Post-graduate diploma in QARA program

Tools

SAP

Word

Excel

Job description

Value Proposition

As a leading partner in healthcare, Medline Canada's sole purpose is Together Improving care – 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

The QA Specialist assists in implementing and maintaining the Quality Systems of Medline Canada. The Quality Assurance Specialist is responsible for creating and maintaining device master records (DMRs), qualifying and conducting vendor evaluations, recommending improvements, generating product specifications, design control files and associated documentation for Medline brand products. The QARA Specialist will also assist in the evaluation of complaints and assist with the management of recalls as required.

CORE JOB RESPONSIBILITIES

• Create Device Master Records (DMRs) for Medline brand and private label Canada-only SKUs by working directly with vendors and Divisions to ensure all necessary documentation is obtained. Obtain all necessary evidence, certificates, test reports etc. to support the safety and efficacy of the products. 30%
• Initiate and lead vendor qualifications.
• Create and maintain specifications for Medline brand Canada-only SKUs by working directly with vendors and Divisions, and update inspection criteria for manufacturing sites. 20%
• Arrange for laboratory testing where necessary to fulfill documentation requirements, either directly with vendor, through Division or independently using 3rd party lab. 10%
• Review methods and procedures for process control, process validation, process improvement, testing, and inspection to ensure that products are ideal and functional.
• Assist with complaint investigations to determine trends and lead corrective actions.
• Direct and collaborate with supplier representatives on quality problems, ensure corrective action implementation (CAPA, SCAR), and contribute to supplier quality improvement programs.
• Provide Quality expertise in Product Development, Design Control activities, Risk Management.
• Perform quality reviews of design documentation for compliance with stated requirements, including vendor quality documents and company quality records.

QUALIFICATIONS

• Bachelor in Engineering or Science with a minimum of 2-3 years of work experience with quality in a GMP/QMS manufacturing or distribution environment.
• Post-graduate diploma in QARA program an asset.
• Professional Quality Certifications such as ASQ an asset.
• Knowledge and experience with quality management systems documentation.
• Knowledge of GMP and QMS principles.
• Knowledge and experience with preparation and maintenance of technical files for medical devices.
• Knowledge and experience with laboratory testing protocols and standards (e.g. USP methods).
• Good English verbal and written communication skills and good interpersonal skills.
• Ability to work effectively and independently with minimum supervision, as well as within a team, managing multiple priorities in a fast-paced environment.
• Detail oriented with analytical mindset and problem solving skills overcoming obstacles, and reaching a positive and successful solution through mathematical or systematic operations.
• Proficiency in computer skills (Word, Excel, PC software applications).
• Experience with SAP an asset.

About Medline Canada

Medline Canada stands at the forefront of healthcare, providing expertise and a breadth of solutions for every care setting. With 550+ employees, including 100 dedicated sales and clinical professionals and eight distribution centres located coast-to-coast, Medline Canada is proud to serve the entire continuum of care.

Our Commitment to Diversity and Inclusivity

Medline Canada is committed to diversity and inclusivity and we encourage applications from members of groups that have been historically disadvantaged and marginalized, including First Nations, Metis and Inuit peoples, Indigenous peoples of North America, racialized persons/persons of colour and those who identify as women, persons with disabilities and LGBTQ+ persons.

Our commitment to Accessibility

Medline Canada is committed to the principles of the Accessibility for Ontarians with Disabilities Act (AODA). We endeavor to make our recruitment, assessment and selection processes as accessible as possible and provide accommodations as required for applicants with disabilities. If you require any accommodations at any point during the application and hiring process, please contact [e-mail].

All qualified candidates are encouraged to apply; however, Canadians and permanent residents will be given priority.