Canada-British-Columbia: Quality Assurance Specialist
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please visit http://sqa.fyicenter.com
Quality Assurance Specialist
* Support new product development activities including developing the quality plans, direction for the application of statistical techniques, reviewing and approving required design and development documentation, and participating in risk management activities and design reviews.
* Provide QA oversight and review to the complaint handling process; participate in meetings to ensure appropriate information is conveyed and corrective action plans are in place.
* Assess adequacy of technical investigations and solutions, including supporting documentation of complaints, MRs, recalls, etc. and provide input or recommendations as appropriate.
* Develop metrics that will reveal cost of quality issues such as data on defect detection, internal and external failures, pre- vs. post-release, conformance and non-conformance, appraisal and preventive actions, etc. Compile and present information as needed to ensure visibility and facilitate resolutions
* Assist with maintaining the site quality metrics reporting system; ensure that quality metrics data are identified and monitored, and periodic trend reports are developed and distributed as required.
* Oversee the evaluation, selection and usage of metrics tools and methodologies, such as six-sigma, lean manufacturing, etc.
* Lead and support customer, regulatory body, supplier and internal audits.
* Manager and execute the Corrective Action and Preventative Action program
* Other duties may be assigned
Education and Experience Required:
* Bachelorís degree in Computer Science or other related discipline.
* Seven years related experience and/or training
* Proven expertise in software engineering practices and quality system regulations
* Ability to read and understand ISO, FDA and related standards and regulations
* Technical skills to enable critical review of software development and testing processes and methods,
* Ability to communicate in technical matters with internal associates, customers, and suppliers
* Demonstrated organizational skills
* Process Control skills with emphasis on Continuous Improvement a plus
* Familiar with Microsoft Word, Microsoft Project, Microsoft Excel, Microsoft PowerPoint, Microsoft Visio, Adobe Acrobat
* 25% travel
To apply for this position, please visit
Team SQAFYI - Software QA Resource FYI