Feb 03, 2021 Job Description
Quality Engineering Specialist - Development
Purpose: Ensure consistent, compliant, quality components and processes for assembly of medical devices by being actively involved in part, device, and process development.
DEVELOPMENT PROJECT SUPPORT
Lead the QA portion of new development projects
Assist in the development of component drawings and finished goods drawings
Lead development of fixtures, gages and inspection equipment
Lead the creation and revision of inspection 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
QUALITY ISSUES IDENTIFICATION AND RESOLUTION
Lead supplier CAPAs of development programs
Investigate and resolve quality issues
Lead the Non-Conformance and Temporary deviation process for development projects
Ensure that adequate supplier process controls are in place for new product launches
Lead assigned Industry 4.0 activities within the QA department
Lead software and equipment validation activities within the QA department
HEALTH AND SAFETY
Ensure compliance with relevant health and safety legislation, including the Workplace Safety and Insurance Act, the Occupational Health and Safety Act, etc.
University degree in mechanical/industrial engineering or related discipline
Professional Engineer designation, or able to acquire designation
5 years of related job experience
Experience in working in an ISO 13485 or another regulated environment is an asset
Experience with GDP and cGMP is an asset
Advanced knowledge using MS Excel and Power BI is an asset
Advanced knowledge using Solid works
Advanced knowledge in statistical methods and data analysis
Advanced knowledge of using and programming CMM’s is an asset
Advanced knowledge of metrology
Advanced knowledge in interpreting blueprints with GD&T
Experience in Lean Manufacturing is an asset
Good understanding of injection molding is asset
Ability to develop, implement and verify measurement techniques and testing of products (silicone and plastic components, electrical components, etc…)
Working knowledge in metal fabrication is an asset
Experience in automation (e.g microcontrollers, plc’s and sensors) is an asset
Experience in project management is an asset
Good oral and written communication
Good interpersonal ability
How to Apply
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
Trudell Medical International
London, ON N5V 5G4
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.