The purpose of the role is to focus on life cycle management activities for projects within medical devices .
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.
PROFESSIONAL EXPERIENCE REQUIREMENTS
• A minimum of a Bachelor’s degree in Engineering or related technical or scientific discipline with a minimum of 5 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 is preferred. • Experience in an Medical Device regulated environment • Strong knowledge and skills in MS Office • Excellent problem solving, decision-making, and root cause analysis skills are required. • Interpersonal skills that foster conflict resolution are required. • 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. • Ability to multi-task independently with minimal supervision • Fluency in English is required, good knowledge of German would be a strong asset.
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Michael Bailey International is acting as an Employment Business in relation to this vacancy.