Design Quality Engineer
A globally renowned pharmaceutical company is seeking to recruit a Design Quality Engineer 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.
- Liaising with all key stakeholders when formulating and communicating the Project Plans.
- Ensuring continual deployment of the MDR Plan through consistent excellence in project management.
- Designing Quality team member focused on life cycle management activities.
- Enhancing the Design Control and Risk Management processes to better reflect the state of the art practices and drive continuous improvement.
- Applying statistical methods and process/design excellence tools to establish test plans as well as evaluate test data and processes.
- Performing Gage R&R studies.
- Conducting and leading design verification and validation activities.
- Conducting and leading design/process failure mode effects and analysis.
- Providing leadership in all areas of the Quality System, including, but not limited to Corrective & Preventive Actions, Complaints, Nonconforming Materials, Risk Management, etc.
- Providing leadership in the understanding of medical device regulations to other disciplines.
- Communicating effectively at all levels within Quality as well as cross-functionally with departments such as Product Development, Regulatory Affairs, Manufacturing, and Marketing.
- Knowing and following 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.
Skills and Requirements:
- A minimum of a Bachelors degree in Engineering or related technical or scientific discipline with a minimum of 7+ years of experience in a 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.
- Fluency in English is required, good knowledge of German would be a strong asset.
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 James Wilson at +44 203 762 2703 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.