Process Quality Engineering Team Lead improving Kardium’s atrial-fibrillation medical-device manufacturing quality. Leading engineers, non-conformance investigations, rework, and continuous improvement across two shifts.
Responsibilities
Develop detailed understanding of Kardium 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 of quality issues in Catheter/Introducer subassembly processes
Review and disposition non-conforming products and materials
Lead NC disposition and rework activities
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 continuously improve processes for monitoring, evaluating, and reporting product quality trends and process performance
Act as 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, and process capability
Ability to lead Process Quality Engineers in a fast-paced manufacturing environment
Ability to work across a two-shift operation
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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