Quality Engineer Specialist - Development

About the job

As a member of our Quality Assurance team, you will lead development of parts, devices, and processes for assembly of medical devices from a QA perspective.

Responsibilities Include:

Lead Manufacturing Quality Engineering Actions for New Product/Part Development

• Lead the QA portion of new development projects.
• Assist in the development of component drawings and finished goods drawings.
• Lead development of automated inspection equipment
• Lead the creation and revision of measurement plans and work instructions.
• Lead the QA portion of manufacturing process control documents.
• Lead supplier PPAP activities for new development projects
• Lead QA portion of the part approval process for new development projects
• Lead transfer activities to Quality Engineering Specialist, Production

Quality Issues Identification & Resolution

• Lead supplier CAPAs of development programs
• Investigate and resolve quality issues for development projects
• Ensure that adequate supplier process controls are in place for new product launch
• Apply statistical process control to strive for high product quality and lower cost.

Departmental Support

• Lead assigned QA Industry 4.0 activities
• Lead QA software and QA equipment validation activities
• Liaise with Quality Engineering Specialist, Production for approval of new suppliers
• Act as backup to the Quality Engineering Specialist, Production.

Health & Safety

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

QUALIFICATIONS

• University degree in mechanical/industrial/electrical engineering or related discipline
• Professional Engineer designation, or able to acquire the designation
• 5 years of related job experience
• Advanced knowledge in statistical methods and data analysis
• Experience in project management
• Experience in automation (e.g. microcontrollers, plc’s and sensors, robotics)
• Advanced knowledge of metrology
• Advanced knowledge using Solid works or equivalent CAD software
• Advanced knowledge in interpreting blueprints with GD&T
• Ability to develop, implement and verify measurement techniques and testing of products (silicone and plastic components, electrical components, etc.)
• Advanced knowledge of using and programming CMM’s is an asset
• Advanced knowledge using MS Excel and Power BI is an asset
• Experience in working in an ISO 13485 or another regulated environment is an asset
• Experience with GDP and cGMP is an asset
• Experience in Lean Manufacturing is an asset
• Good understanding of injection molding is an asset
• Working knowledge in metal fabrication is an asset
• Good oral and written communication
• Good interpersonal ability

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

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