Job Description SummaryThe 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.
Job DescriptionResponsibilities: - 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.
- 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.
- Arrange for laboratory testing where necessary to fulfill documentation requirements, either directly with vendor, through Division or independently using 3rd party lab.
- 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.
The anticipated salary range for this position:
$66,500.00 - $99,700.00 Annual
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.
