Your responsability and functions: • Quality Engineering/Design or Process Excellence/Lean experience is preferred. ASQ certifications are an asset. • Strong engineering skills with working knowledge of : Process validation/verification activities. • Knowledge of the QSR, Design Controls, and ISO quality requirements. A minimum of 1 years of related experience is required, preferably within a regulated environment (e.g. FDA regulated). • Experience conducting Process / Design Failure Mode Effects and Analysis. • Mechanical product knowledge is preferred. 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. • Engineering, Technical, or Scientific discipline is required. An advanced degree in a related field is an asset. • 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. • Experience in CAPA execution and management.
• Minimum 5 years of relevant experience in medical device sector.
• Working knowledge of Microsoft office products (Word, Excel, Access, and Project).
• Excellent written and oral communication skills.