About you:
You desire responsibility for developing and maintaining quality systems and providing quality engineering support in a new product development, manufacturing environment. You have prior experience in Medical Device Quality Assurance working on standards and regulations like ISO 13485, 21 CFR 820, etc., and have had exposure to providing Quality and Compliance support related to the design and development, manufacturing, and distribution of medical devices.
What you’ll do:
Identify and implement effective Quality Management systems to support the development, qualification, and ongoing manufacturing of IVD devices to meet or exceed internal and external requirements;
Lead, coach, and mentor colleagues on QMS requirements to ensure compliance;
Assist in the development and execution of streamlined systems which effectively identify and resolve quality issues;
Work closely with the Process Development and Assay Development teams to ensure adequate documentation is in place to support development and manufacturing activities
Review various design and development protocols to ensure compliance with applicable regulations and standards and to support product design and development activities;
Ensure compliance with cGMP, QSR, ISO13485, IVDR, and other applicable regulations/standards;
Lead process controls and monitoring of CTQ parameters and specifications;
Collaborate with manufacturing personnel in implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing);
Coordinate and facilitate Nonconformances and Material Review Board (MRB) activities;
Support completion and maintenance of risk analysis;
Perform root cause analysis as
part of corrective and preventive actions or non-conformance investigations and ensure all documentation is adequate to withstand any external audits, inspections, etc;Support and implement CAPAs, Change controls, non-conformances, deviations, routine documentation activities, implementation of the QMS in day-to-day activities and adherence to quality KPIs;
Participate as a Quality Representative on various design and development projects.
Work closely with other QA Members on various QA Projects
What you’ll need:
Minimum Bachelor’s degree in Life Sciences (Biology, Biochemistry, Microbiology, Molecular/ Cell biology)
5+ years of Quality Assurance 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., Six Sigma, Lean manufacturing, etc.);
Excellent organizational, verbal, written communication, and problem-solving skills;
Ability to work in a fast-paced environment and to meet tight deadlines;
Quality Assurance 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.
Bonus points for:
Certified Quality Auditor (ASQ CQA) or Certified Quality Engineer (ASQ CQE);
Knowledge of statistical sampling and analysis;
Experience working in a start-up environment;
Proficiency in MS Office Suite, SolidWorks, Visio, and Project;
What we have to Offer:
An opportunity to change the face of medical diagnostics for everyone;
An environment full of high-functioning, motivated, and passionate teammates;
An environment where one can showcase their talents and know that those contributions are valued each and every day.
About Vital
Vital is revolutionizing point-of-care diagnostics with our VitalOne platform, delivering real-time care wherever patients are. Our mission is to democratize health technology, making healthcare more accessible and proactive.
Our global team of experts spans chemistry, software, engineering, and microfluidics. We thrive on change, operate on trust, and value diverse perspectives. Our growth-minded culture empowers front-line decision-making and fosters impactful work.
We seek tenacious, bold individuals ready to transform healthcare. At Vital, your talent will make a difference as we work to ensure everyone has access to care when and where they need it.
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. If you require accommodation in order to participate in our hiring process, please contact us to make your needs known in advance.
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