Quality Technologist Systems

Quality Technologist Systems (Level 3, Weekends, Midnight)

As a member of our Quality Assurance team, you will develop and initiate measurement techniques and plans that support current and new development programs. Provide service to internal and external customers. Administer and review quality system documents. Participate in general problem solving activities and process improvement initiatives

 

Responsibilities Include:

 

New and Ongoing Product Support

  • Ensure to measure parts for suppliers and Product Development staff, as required
  • Ensure to communicate with suppliers on measurement issues, as required
  • Conduct Inspection Requests
  • At Level 2: Ensure that measurement plans are reviewed, generated, and maintained
  • At Level 2: Ensure that measurement plans are agreed to with suppliers
  • At Level 3: Ensure to review and forward PPAP documentation for approval
  • Process at Level 2: Developing fixtures as necessary, working with external resources (suppliers) or internal resources (engineers, quality specialist or level 3 technologist)
  • Process at Level 2: Ensure to develop OGP Smart-Scope routines
  • Process at Level 3: Developing fixtures using SolidWorks
  • Process and Systems at Level 2: Troubleshooting of automated QA equipment
  • Process and Systems at Level 3: Support implementation of automated QA equipment
  • Process and Systems at Level 3: Lead investigation of new measurement equipment and methods
  • At Level 2: troubleshoot OGP Smart-Scope routines

 

In-coming and In-process Inspection

  • Ensure to perform required incoming inspection with calibrated measurement equipment according to measurement plans
  • Ensure to 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 at Level 2: 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 at Level 2: 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

 

Gauge Maintenance

  • Ensure to use quality tools and practices for analysis of data, e.g. 5 Why’s, root cause analysis, Pareto charts, statistical techniques, etc.
  • At Level 2: Ensure to prepare and distribute reports on data analysis
  • Process at Level 3: Lead correlation studies and provide analysis and recommended actions
  • Systems at Level 3: Extract and analyze Data out of multiple sources, including SQL databases

 

Departmental Support

 

  • Ensure to participate in external audits as required by writing audit reports and issuing corrective actions
  • Ensure to 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 (blueprints, and measurement plans)
  • At Level 2: Ensure to assist in the training of Quality Technologists and Inspectors
  • QMS at Level 2: Lead master sample and boundary sample process
  • QMS at Level 2: Review and approve DHRs
  • QMS at Level 2: Lead internal CAPA process coordination
  • QMS at Level 3: Lead internal audit process
  • QMS at Level 3: Act as a coach for investigations and root cause analysis of internal CAPAs
  • Systems at Level 2: Participate actively in Industry 4.0 initiatives
  • Systems at Level 3: Lead industry 4.0 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:

 

EDUCATION AND EXPERIENCE

 

  1. Diploma or Certificate in quality assurance or manufacturing engineering or a related field of study
  2. Level 1: College diploma or Quality Certificate or three years experience working in  a quality, metrology, and/or manufacturing environment
  3. Level 2: College diploma in a relevant technical field, e.g. quality assurance, manufacturing engineering, etc. or minimum 1 year experience as level 1 or four years experience working in  a quality, metrology, and/or manufacturing environment
  4. Level 3: College diploma in a relevant technical field, e.g. quality assurance, manufacturing engineering, etc. or university degree in engineering or minimum 1 year experience as level 2
  5. Level 3: Five years experience in a quality, metrology, and/or manufacturing environment.

 

SPECIALIZED SKILL or KNOWLEDGE

 

  1. K Knowledge of a quality system program is an asset
  2. General knowledge of Good Manufacturing Practices (GMPs)
  3. Basic math and computer skills are assets:
    1. Intermediate experience in MS Word
    2. Intermediate experience in MS Excel
    3. Intermediate experience in MS Outlook or comparable email and scheduling software
  4. Ability to read and interpret blueprints with geometric dimensioning and tolerancing (GD&T), through experience or education (e.g. college level blueprint reading course)
  5. Ability to develop, implement and verity measurement techniques and testing of products and processes
  6. Audit experience is an asset
  7. Ability to handle multiple projects at the same time with excellent follow up skills
  8. Good analytical skills, with general knowledge of statistical and quality tools
  9. Effective customer and supplier relation skills and good interpersonal skills
  10. Excellent oral and written communication skills
  11. Ability to work independently
  12. Excellent organizational, especially in completing accurate and legible reports
  13. Excellent vision and attention to detail
  14. Experience in the use of OGP SmartScopes
  15. Level 2 Process: Experience in programming OGP SmartScope routines with vision and touch-probes
  16. Experience working in an ISO 13485 system environment
  17. Level 3 Process: Experience in the use of SolidWorks to create fixture and assembly drawings
  18. Level 2 Systems: Knowledge of PLC programming is an asset
  19. Level 3 Systems: Experience with data analysis software (e.g PowerBI, Excel including VBA and SQL query)

 

ESSENTIAL DUTIES

 

  1. Good manual dexterity with the ability to assemble small parts in a fast-paced environment
  2. Demonstrated ability to work in a close team environment
  3. Ability to safely lift 10-15 pounds on a regular basis
  4. Ability to safely lift 15-30 pounds on an occasional basis

 


 

How to Apply

Email
hr [at] trudellmed.com

  • Include a résumé and cover letter which includes the job title
  • Use Microsoft Word .doc or .rtf formats
  • Include the job title and your name in the title of both Word documents
  • Include the job title in the Subject line of your email

Mail
Human Resources
Trudell Medical International
London, ON  N5V 5G4
Canada

 


 

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

Please send your résumé only once per position.

Résumés will be accepted throughout the process, but only candidates selected for interviews will be contacted.

TMI is an equal opportunity employer.

We thank all applicants in advance for their interest in joining our team.