Senior Quality Technologist

About the job

At Trudell Medical International (TMI), we pride ourselves on our passion for finding innovative and creative solutions which has enabled us to develop medical devices that continue to make a difference in the lives of people around the world. Situated within a modern facility located in beautiful London, Ontario, TMI offers a comfortable work environment with a respectful and family-oriented culture.

As an employee of Trudell Medical International, not only will you contribute to the development of products at the cutting edge of medical device technology, but you will also have the opportunity to perform challenging work alongside a first-rate group of dedicated professionals.

We’re actively searching for our next team member for the position of:

Senior Quality Technologist

Purpose: Provide technical leadership and support to Quality Technologists and Quality Inspectors in maintaining and developing measurement techniques and plans to support current and new development programs. Set an example for high quality services when communicating with internal teams and external customers/suppliers. Administer, review, and maintain quality system documents. Contribute to general problem solving activities and process improvement initiatives.

Responsibilities Include

NEW and ongoing product support

• Measure parts for suppliers and Product Development staff, as required
• Communicate with suppliers on measurement issues, as required
• Conduct Inspection Requests
• Ensure that measurement plans are reviewed, generated, and maintained
• Ensure that measurement plans are agreed to with suppliers
• Ensure to review PPAP documentation for completeness and accuracy, highlighting issues prior to forwarding for approval
• Process: Lead the development of fixtures as necessary, working with external resources (suppliers) or internal resources (engineers, quality specialist or level 3 technologist)
• Process: Develop OGP SmartScope routines
• Process: Troubleshoot OGP SmartScope routines
• Process: Developing fixtures using SolidWorks
• Process and Systems: Troubleshooting of automated QA equipment
• Process and Systems: Support implementation of automated QA equipment
• Process and Systems: Lead investigation of new measurement equipment and methods
   

• Perform required incoming inspection with calibrated measurement equipment according to measurement plans
• Perform in-process inspections leading to the release of components and finished goods as required
• Ensure all products are assembled following Assembly Procedures, Standard Operating Procedures, Good Manufacturing Practices, and in accordance with the Quality Policy Objectives
• QMS and Systems: Lead investigations related to product and processes (non-conformance reports (NCRs), temporary deviations (TDs), and corrective and preventative action (CAPAs)) by gathering and analyzing data and resolving or facilitating resolution
• QMS and Systems: Lead documentation and resolution of non-conformance reports (NCRs) and temporary deviations (TDs) by preparing NCRs and routing them for approval and review TDs and adjust inspections accordingly
   

• Use quality tools and practices for data analysis, e.g. 5 Why’s, root cause analysis, Pareto charts, statistical techniques, etc.
• Ensure to prepare and distribute reports on data analysis
• Process: Lead correlation studies and provide analysis and recommended actions
• Process: Extract and analyze data from multiple sources, including SQL databases
   

• Perform Gauge Repeatability and Reproducibility (GR&R), as required and generate records
• Perform Gauge calibration, as required, and generate records
• Ensure to manage calibration records in GageTrak, as required
• Ensure to generate, document, and maintain calibration procedures as required
   

• Participate in external audits as required by writing audit reports and issuing corrective actions
• Participate in cross-functional teams as a Quality representative, including Supplier Quality, and Engineering, as required
• Lead Quality development programs with the focus on continuous improvement
• Lead measurement plan process improvements
• Participate with internal audit team as required
• Participate in program launch reviews as required (drawings, fixtures and measurement plans)
• Ensure to assist in the training of Quality Technologists and Inspectors
• Lead master sample and boundary sample process
• Review and approve DHRs
• Lead internal CAPA process coordination
• Lead internal audit process as required
• Act as a coach for investigations and root cause analysis of internal CAPAs
• Lead automated QA equipment initiatives
   

• Ensure compliance with relevant health and safety legislation, including the Workplace Safety and Insurance Act, the Occupational Health and Safety Act, etc.
   

• Diploma or degree in a relevant technical field, e.g. quality assurance, manufacturing engineering, etc.
• 5+ years of experience in quality or metrology in a manufacturing environment
• Knowledge of a quality system program is an asset
• General knowledge of Good Manufacturing Practices (GMPs)
• Intermediate experience in MS Office
• Ability to read and interpret blueprints with geometric dimensioning and tolerancing (GD&T), through experience or education (e.g. college level blueprint reading course)
• Experience in the use of OGP SmartScopes
• Experience in programming OGP SmartScope routines with vision and touch-probes
• Experience in the use of SolidWorks to create fixture and assembly drawings
• Ability to develop, implement and verify measurement techniques and testing of products and processes
• Audit experience is an asset
• Ability to handle multiple projects at the same time with excellent follow up skills
• Good analytical skills, with general knowledge of statistical and quality tools
• Effective customer and supplier relation skills and good interpersonal skills
• Excellent oral and written communication skills
• Ability to work independently
• Excellent organizational skills, especially in completing accurate and legible reports
• Experience working in an ISO 13485 system environment
• Knowledge of PLC programming is an asset
• Experience with data analysis software (e.g PowerBI, Excel including VBA and SQL query)
• Demonstrated ability to work in a close team environment
   

We are an equal opportunity employer and it is important to our Company that all its employees, including those with disabilities, find our workplace to be welcoming and supportive. If you are a candidate with a disability who requires accommodations during the recruitment process, please let us know.

Apply via LinkedIn