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:
QUALITY TECHNOLOGIST
As a member of our Quality Assurance team, you will maintain, develop, and implement measurement techniques and plans to support current and new development programs. Provide support services to 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
Process: Developing fixtures as necessary, working with external resources (suppliers) or internal resources (engineers, quality specialist or senior technologist)
Process: Ensure to complete validation processes of fixtures (validation, GR&R, correlation)
Process: Develop OGP SmartScope routines
Process: Troubleshoot OGP SmartScope routines
Process and Systems: Troubleshooting of automated QA equipment
In-coming and In-process Inspection
Perform required incoming inspection with calibrated measurement equipment according to measurement plan
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 or support 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 or support 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
Data Analysis
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
Gauge Maintenance
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
Departmental Support
Participate in cross-functional teams as a Quality representative, including Supplier Quality, and Engineering, as required
Participate in Quality development programs with the focus on continuous improvement
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
Process: Lead master sample and boundary sample process
QMS: Review and approve DHRs
QMS: Lead internal CAPA process coordination
Systems: Support the development of new automated QA equipment initiatives
Health and Safety and Policy Compliance
Ensure compliance with relevant health and safety legislation, including the Workplace Safety and Insurance Act, the Occupational Health and Safety Act, etc.
QUALIFICATIONS
Diploma or degree in a relevant technical field, e.g. quality assurance, manufacturing engineering, etc.
3-5 years of experience working in a 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
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
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.
