Description
We are looking for a Design Quality Engineer for a Global Medical Device company in near Basel. This is a 12-month contract and you will be involved in MDR projects.Responsibilities:
- 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 of clear definition of project scope and deliverables, milestones and timeline, project risks and contingency plans.
Requirements:
- A minimum of a Bachelor's 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 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.
Kontakt: Luchele Mendes
Michael Bailey International is acting as an Employment Business in relation to this vacancy.