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 for clear definition of project scope and deliverables, milestones and timeline, project risks and contingency plans
Bachelor’s degree in Engineering or a related technical or scientific discipline with profound and in-depth experience in a related field
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
Experience in an Medical Device regulated environment
Strong MS Office knowledge and skills
Excellent problem solving, decision-making, and root cause analysis skills
Interpersonal skills that foster conflict resolution
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
Fluency in English is required, good knowledge of German would be a strong asset
A very renowned company
A highly motivated team and an open way of communication
You will work in an international environment
As a modern company, our client manages to constantly develop further and break new ground.
Über Hays: With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
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