Senior Quality Technologist

3 weeks ago

London ON, Canada Trudell Medical International Full time

As a member of our Quality Assurance team, you will 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
  • Lead the development of fixtures as necessary, working with external resources (suppliers) or internal resources (engineers, quality specialist or level 3 technologist)
  • Develop OGP SmartScope routines
  • Troubleshoot OGP SmartScope routines
  • Developing fixtures using SolidWorks
  • Troubleshooting of automated QA equipment
  • Support implementation of automated QA equipment
  • Lead investigation of new measurement equipment and methods

IN-COMING AND IN-PROCESS INSPECTION

  • 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
  • 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
  • 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

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
  • Lead correlation studies and provide analysis and recommended actions
  • Extract and analyze data from multiple sources, including SQL databases

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 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

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.
  • 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

At an applicant’s request, TMI will make accommodation to its recruitment process to meet the needs of applicants with disabilities.

Job Types: Full-time, Permanent

Benefits:

  • Dental care
  • Employee assistance program
  • Extended health care
  • Life insurance
  • On-site parking
  • Paid time off
  • RRSP match

Schedule:

  • 8 hour shift
  • Day shift
  • Monday to Friday

Work Location: In person

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