Quality Assurance Performance Engineer Junior

1 month ago

Mississauga ON, Canada Vitalbio Full time

You desire responsibility for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support. You have prior experience working as a Quality Engineer, preferably in a medical device company based on standards and regulations (ISO 13485, 21 CFR 820, etc.), and have had exposure to providing Quality and Compliance support related to the design and development, manufacture, and distribution of medical devices.
Identify and implement effective process control systems to support the development, qualification, and ongoing manufacturing of products to meet or exceed internal and external requirements;
Assist in the development and execution of streamlined systems which effectively identify and resolve quality issues;
Lead process control and monitoring of CTQ parameters and specifications;
Lead completion and maintenance of risk analysis;
Perform root cause analysis and implement quality control solutions as required for corrective and preventive actions and ensure all documentation is adequate to withstand any external audits, inspections, etc;
Participate as a Quality Representative on various design and development projects.
Minimum Bachelor’s degree in STEM;
~5+ years of Quality Engineering experience in a manufacturing or industrial environment, preferably in an FDA-regulated environment;
~ Knowledge of ISO, FDA, and QSR concepts and guidelines as well as other national and international regulations and standards;
~ Experience performing quality audits and utilizing manufacturing processes, techniques, and continuous improvement methodologies (i.e., Engineering experience and demonstrated use of Quality tools and methodologies;
~ Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues promptly and effectively.

Certified Quality Auditor (ASQ CQA) or Certified Quality Engineer (ASQ CQE);
Knowledge of statistical sampling and analysis;
Proficiency in MS Office Suite, SolidWorks, Visio, and Project;
An opportunity to change the face of medical diagnostics for everyone;
Vital Biosciences Inc. is an equal-opportunity employer and values diversity in the workplace. We are therefore happy to accommodate any individual needs in keeping with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act.

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