Quality Assurance Engineer

Vitalbio; Oakville; On-site; CAD 70,000 - 90,000; Full time

Job summary

Vitalbio is seeking a Quality Engineer dedicated to enhancing medical device development and compliance. The ideal candidate will have extensive experience in Quality Engineering within FDA-regulated settings, leading quality initiatives and collaborating with cross-functional teams to uphold high standards. Join a mission-driven team aiming to change healthcare accessibility through innovative diagnostics.

Benefits

Opportunities to impact medical diagnostics

Collaborative and passionate team environment

Qualifications

• 5+ years of Quality Engineering experience, preferably in medical devices.
• Knowledge of ISO, FDA, and QSR guidelines.
• Ability to read blueprints and interpret GD&T.

Responsibilities

• Lead, coach, and mentor on QMS Requirements.
• Ensure compliance with regulations like ISO13485.
• Perform root cause analysis and implement quality control solutions.

Skills

Quality Engineering

Problem Solving

Communication

Project Management

Leadership

Education

Bachelor’s degree in STEM

Tools

MS Office Suite

SolidWorks

Visio

Job description

About you:

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.

What you’ll do:

• 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;

• 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;

• Review various design and development protocols to ensure compliance with applicable regulations and standards;

• Ensure compliance with cGMP, QSR, ISO13485, IVDR, and other applicable regulations/standards;

• Lead process control 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;

• 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;

• CAPA actions to Support validations for new and existing products, processes, and equipment;

• Participate as a Quality Representative on various design and development projects.

What you’ll need:

• 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;

• Ability to read blueprints and interpret Geometric Dimensioning and Tolerances (GD&T);

• 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;

• 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.

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;

• Appreciate of puns!

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.