Quality Engineering Specialist

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. 

RESPONSIBILITIES INCLUDE:

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

COMPONENT APPROVAL

  • 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

DEPARTMENTAL SUPPORT

  • 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.

 

QUALIFICATIONS:

  • 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

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.