Job Title

As a member of our Regulatory Affairs team, you will be responsible for ensuring the quality and consistency of supplier processes and components provided by suppliers. This role involves developing and maintaining strong supplier relations by spending on-site time with suppliers, conducting audits and working closely with suppliers to resolve quality issues. This position requires: Domestic and international travel required (up to 50%) Ability to connect virtually at specified time frame that accommodates time zone differences (examples: 8am EST or 8pm EST) Responsibilities Include: Supplier Quality / Development Assist in the development of component / part drawings Lead supplier PPAP activities Complete Production Part Approval Process / Part Validation (IQ/OQ/PQ) in cooperation with suppliers Establish control plans jointly with suppliers for review by TMI Assist in the creation and revision of inspection plans and work instructions Track assigned supplier quality metrics and report periodically to TMI utilizing a supplier scorecard (on time shipments, short shipments, capability by part number and SC, material review board) Work with assigned suppliers to improve processes and reduce cost. Manage component and material changes at the supplier ensuring timelines are met, capability is present, and validation of parts are completed. Supplier Quality Issues Identification & Resolution Lead supplier CAPAs Investigate, analyze and correct problems in quality, production and control at a supplier location. Ensure that adequate supplier process controls are in place Apply statistical process control to strive for high product quality and lower cost. Supplier Audits Evaluate assigned suppliers and complete observation reports Ensure systems and procedures for traceability, calibration, change control, training, etc.are implemented Ensure Manufacturing documents and processes such as process flow, PFMEAs, process controls, random inspection of parts online, etc. are implemented and used effectively Ensure manufacturing processes comply with requirements and procedures Ensure vendor inventory meets TMI forecast requirements Ensure compliance with TMIs ethical and responsible sourcing requirements by auditing suppliers for compliance and declaring any non-conformances observes. Third Party Inspection and Containment Manage vendor inspection capacity and forecast Plan and coordinate inspection of TMI parts at a 3rd party, if required. 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/electrical engineering or related discipline Professional Engineer designation, or able to acquire the designation is an asset 5 years of related job experience. Advanced knowledge in statistical methods and data analysis Experience in project management Advanced knowledge of metrology 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 CMMs 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 Excellent communication and liaison skills Good interpersonal ability Fluent in written and spoken in the language of the assigned territory is an asset At an applicants request, TMI will make accommodation to its recruitment process to meet the needs of applicants with disabilities.