Process Quality Engineering Team Lead overseeing quality investigations and non-conformance disposition for Kardium’s atrial-fibrillation medical device manufacturing operations. Leading engineers across a two-shift production environment.
Responsibilities
Develop a detailed understanding of Kardium’s products and manufacturing processes
Lead a team of Process Quality Engineers in a fast-paced manufacturing environment
Triage, prioritize, and schedule operational and project work
Lead investigations with engineering subject matter experts
Review and disposition non-conforming products and materials
Lead NC disposition and rework activities for Catheter/Introducer subassembly processes
Support and drive continuous improvement initiatives
Investigate systemic product quality issues
Build and maintain cross-functional partnerships with Quality Control, Engineering, Manufacturing, and Quality Assurance
Design, implement, and improve processes for monitoring, evaluating, and reporting product quality trends and process performance
Act as the primary point of contact for production quality concerns across a two-shift operation
Requirements
Bachelor’s degree or higher in science or engineering
Mechanical engineering background preferred
At least 8 years of engineering experience in a technical, multi-disciplinary environment
Experience with medical devices or similarly regulated industries highly advantageous
Excellent interpersonal skills and track record of driving consensus with diverse stakeholders
Excellent written and verbal communication skills, especially in a technical context
Proven experience with non-conformances, failure investigations, root-cause analysis, and quality engineering tools
Sound knowledge of statistics, SPC, FMEA, process capability, and related concepts
Benefits
5% RRSP contribution
Stock option plan for permanent employees
Comprehensive medical and dental coverage effective Day 1, with no waiting period
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