Design Quality Engineer

The purpose of the role is to focus on life cycle management activities for projects within medical devices.

Tasks:

. 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.

Please send your CV

Michael Bailey International is acting as an Employment Business in relation to this vacancy.