Design Quality Engineer

A global life science conglomerate is looking to hire a Design Quality Engineer to join their team in Zuchwil, Switzerland on a contract basis.

Job Responsibilities:

• This Design Quality job witll be 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.
• 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.

Education, Skills and Experience:

• A minimum of a Bachelors 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 is preferred.
• Experience in a 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
• Working knowledge of material science and mechanical product knowledge is preferred.
• Development and manufacturing experience is preferred.
• Minimum Language required Fluency in English is required, good knowledge of German would be a strong asset.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Caleb Mensah on +44 203 854 1080 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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