For our Medical Device client we are recruiting for a Design Quality Engineer who will assist in the design and quality efforts with Orthopaedics. This is a contract position for 1 year.
* Design Quality team member focused on life cycle management activities.
* Enhance the Design Control and Risk Management processes to better reflect state of the art practices and drive continuous improvement.
* Apply statistical methods and process/design excellence tools to establish test plans as well as evaluate test data and processes. Perform Gage R&R studies.
* Conduct and lead design verification and validation activities.
* Conduct and lead design / process failure mode effects and analysis.
* Provide leadership in all areas of the Quality System, including, but not limited to Corrective & Preventive Actions, Complaints, Nonconforming Materials, Risk Management, etc.
* Provide leadership in the understanding of medical device regulations to other disciplines.
* Communicate effectively at all levels within Quality as well as cross functionally with departments such as Product Development, Regulatory Affairs, Manufacturing, and Marketing.
* Know and follow all laws and policies that apply to the job, and maintain the highest levels of professionalism, ethics and compliance at all times.
* Accountable for the successful delivery of multiple simultaneous projects, spanning multiple functional areas and locations.
* Responsible of clear definition of project scope and deliverables, milestones and timeline, project risks and contingency plans.
* A minimum of a Bachelor’s degree in Engineering or related technical or scientific discipline with a minimum of 7+ years of experience in related field is required.
* Proven exceptional written and oral presentation skills
* Working knowledge of Design Controls, GMPs, QSR, 21 CFR 820, MDD 93/42/EEC, ISO13485 and ISO14971 quality requirements is required.
* Previous Quality Engineering experience.
* Experience in an Medical Device regulated environment
* Strong quality engineering skills with a proven track record in design verification/validation, process verification/validation, and design/process Failure Mode and Effects Analysis is preferred.
* Excellent problem solving, decision-making, and root cause analysis skills are required.
* Interpersonal skills that foster conflict resolution are required.
* Ability to multi-task independently with minimal supervision
* Working knowledge of material science and mechanical product knowledge
* Development and manufacturing experience is preferred.
Please send CVs or call +41 (0) 44 215 2051
Michael Bailey International is acting as an Employment Business in relation to this vacancy.