We are searching for a quality engineer for a remediation project to support compliance with new medical devices regulations.
• Strong engineering skills with working knowledge of: Process validation/verification activities.
• Knowledge of the QSR, Design Controls, and ISO quality requirements.
Experience conducting Process / Design Failure Mode Effects and Analysis.
• Problem solving techniques including 8D, root cause analysis and cause and effect analysis.
• Knowledge on Statistical techniques and methods.
• Experience with Blueprint reading/literacy including Geometric Dimensioning and Tolerance (GD&T).
• Familiarity with inspection methods and techniques.
• Ability to use Quality Engineering principles, tools, and practices to develop and optimize systems and processes that are aligned with the overall business and quality vision is required.
• Ability to work independently and partner with a cross-functional team (R&D, Regulatory, Manufacturing, and Purchasing).
• Excellent negotiation, decision-making, and interpersonal skills that foster conflict resolution as it relates to technical situations is desired.
• Working knowledge of Microsoft office products (Word, Excel, Access, and Project).
• Excellent written and oral communication skills.
• Experience in CAPA execution and management.
Languages: French and English fluent
Please send your CV
Michael Bailey International is acting as an Employment Business in relation to this vacancy.