Quality Engineering Specialist - 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