Design Quality Engineer
A globally renowned pharmaceutical company is seeking to recruit a Design Quality Engineer - Senior to their office in Switzerland. The organisation works across a range of industries, from medical devices to pharmaceutical and consumer goods, and operates in over 60 countries. This position offers an exciting opportunity to work with a prestigious and historic pharmaceutical establishment and provide real regulatory expertise.
- 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 and 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.
- Successfully deliver multiple simultaneous projects that span multiple functional areas and locations.
- Clearly define project scope and deliverables, milestones and timeline, project risks, and contingency plans.
Skills and Requirements:
- A minimum of a Bachelor's degree in Engineering or related technical or scientific discipline.
- A minimum of 7+ years of experience in related field is required.
- 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 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.
- 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.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
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 contact Caleb Mensah at +44 203 854 1080 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
Un concepteur et développeur de premier plan du projet de cœur artificiel total le plus avancé au monde recherche actuellement un responsable des méthodes industrielles.
Frankfurt am Main, Germany
Device Support Specialist - Frankfurt