Job opening - Software Quality Assurance Lead (SQA Lead) at Titan Medical Inc. (Hamilton, ON, Canada)

Our client, Titan Medical Inc., is seeking a Software Quality Assurance Lead (SQA Lead).Based at its Ancaster facility, you will provide quality assurance guidance to the innovation of next generation medical devices.  In partnership with product development teams, you will apply your software, design controls, verification and validation skills sets to contribute to the development of products that assist doctors and clinicians to diagnose and treat patients more effectively.

Responsibilities include: 

• Providing design control guidance to internal and external development teams;


• Providing quality assurance evaluation and input through actively participating in the design, development, and end user testing of the applications;


• Developing, reviewing, editing and approving software design and development plans;


• Developing overall test strategy, schedule ! and resource planning;


• Reviewing and approving software specifications, and software test procedures and results;


• Conducting feature testing, regression testing, boundary testing, and performance testing;


• Contributing to, and executing testing against, test strategy, test plans and test designs;


• Participating in risk assessment activities (FMEAs, FTAs etc.), clinical evaluation activities and performing traceability activities to ensure that the product meets its requirements and intended use;


• Coordinating overall testing effort with development to ensure project schedules/release scope do not compromise product quality;


• Reviewing test results, tracking test coverage and defecting trends to conduct overall product health assessment and ship readiness.

The ideal candidate will have:

• BSc degree in Computer Science (or related fiel! d) or equivalent work experience;


• 5+ years' work! experience in software testing and quality assurance;


• Previous experience in the Medical Device industry is preferred (experience in Defence or Aerospace industries is also acceptable);


• Experience in project management and the software development lifecycle;


• Experience with internet based technologies and testing with web-based applications;


• Knowledge of FDA Quality System Regulation (21 CFR Part 820);


• Experience working in an iterative, agile development process;


• Strong written and verbal communication skills;


• Willingness to  travel (some travel involved);


• Experience with Windows and embedded development environments is desired;


• Quality certifications (CSQE) are an asset.

 How to Apply:

This is an exciting opportunity and will appeal to the individual who enjoys the challenges tha! t comes with being a part of a growing, entrepreneurial organization.

Interested candidates should submit a cover letter and resume to jfrench@pivotalsolutions.com quoting    "SQA Lead" in the subject line.  To be considered, please reply outlining salary expectations.

We thank all candidates for their interest; however only those most qualified will be contacted.

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