Careers at ThermoFisher Scientific

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Job ID :
Location :
Canada - Burlington
Job Description
Job Title:Sr. Quality Specialist
Reports to: Sr. Director and GM

Position Summary:
  • The Quality Specialist drives the implementation of the quality system requirements and works with various functional groups to ensure that the quality system is maintained and effective.
  • This individual serves as the Management Representative and primary contact for quality and compliance related subjects
  • Able to work collaboratively with various departments to identify and implement solution to address quality and compliance issues.
  • Responsible for developing and implanting quality planning techniques for new product introductions
  • Promotes team oriented interactions. Creative in approach to meeting requirements with technical input.
  • Works with senior management to continuously develop and improve the quality program
  • Shows strong critical thinking skills.

Major Responsibilities:
  • Determine appropriate quality system and implement processes and procedures across the organization. Oversees the quality system to ensure it is suitable, adequate and effective
  • Coordinates cross-functional activities (Hardware, Software, Marketing, Manufacturing, Service, etc.) to achieve compliance with all appropriate quality system and regulatory requirements (internal and external).
  • Leads the culture change and is able to achieve site-wide program success through measurable activity and metrics
  • Strong ability to lead cross-functional team in the execution and reporting of quality improvement projects in the area of focus. This includes but is not limited to: working with teams to perform and document the Risk Management activities, plan and conduct internal and supplier audits, interpret regulator requirements and implement processes to meet those requirements. Divisional and corporate regulatory affairs personnel to clarify requirements as necessary
  • Establish and use Key Business Indicators (KBI) to determine process effectiveness, identify areas for improvement, implement best practices and drive continuous improvement
  • Drives consistent Quality tools across the business unit
  • Establish and participate in appropriate supplier qualification/development activities to ensure that products meet design and manufacturing and quality requirements.
  • Evaluate and implement protocols and methods to ensure that incoming material and manufactured products are compliant with internal requirements as well as the standards/regulations for worldwide distribution
  • Perform analysis of reports to identify trends and recommend necessary corrective actions
  • Drive corrective, preventative, and closure actions for project issues related to quality and/or test non-conformances
  • Active involvement and support in internal and external audits
  • Communicates with customers on as needed basis for significant and reoccurring quality issues

Education Qualifications:
  • College diploma or University degree in Quality Management, Electrical, Mechanical or Manufacturing engineering
  • ASQ Black Belt or Green Belt certification CQE, CQA or CQM or other related certifications are preferred.

Experience Qualifications:
  • Experience applying a variety of tools and techniques that lead to significant product quality, manufacturing and cost improvement is required
  • 3-5 years’ experience in a Quality position, preferably in an ISO environment.
  • 3-5 years’ experience with Quality Management Systems, ISO 9001:2000, FAI, CAPA programs & Continual Improvement implementation.
  • 2-3 years experience as an Internal ISO 9001:2000 Auditor.
  • Experienced with the use and care of precision measuring equipment, interpretation of engineering drawings, and specifications.
  • Excellent working knowledge of Microsoft Word, Excel and PowerPoint.
  • Clear communicator with a strong attention to detail, works well under minimal supervision, positive, outgoing, able to teach and work well with others.

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