Design Quality Engineer - Normal
ProClinical is advertising a vacancy for a Design Quality Engineer - Normal with one of the most prestigious and renowned pharmaceutical companies in the world. This company works across a range of industries from medical devices to pharmaceutical and consumer goods, operating in over 60 countries. The Design Quality Engineer will join this organisation in their office in Switzerland.
This is a short term role, lasting three months, with a possible extension of another three months.
- Enhancing the Design Control and Risk Management processes to better reflect 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 maintaining the highest levels of professionalism, ethics and compliance at all times.
- Being accountable for the successful delivery of multiple simultaneous projects, spanning multiple functional areas, and locations.
- Clearly defining project scope and deliverables, milestones and timeline, project risks and contingency plans.
- Additional duties as assigned.
Skills and Requirements:
- A minimum of a Bachelor's degree in Engineering or related technical or scientific discipline with a minimum of seven 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 quality engineering skills with a proven track record in design verification/validation, process verification/validation.
- Skills in designing/processing Failure Mode and Effects Analysis is preferred.
- Working knowledge of material science and mechanical product knowledge is preferred.
- Development and manufacturing experience is preferred.
- Proficiency in German would be a strong asset.
- Capable of working independently, analysing, working with attention to detail, process and prioritise sensitive complex information, and solve problems.
- 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 in 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 + 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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