For our customer, a leading medical device company with a manufacturing site near Solothurn (Switzerland), we are looking for an experienced
Design Quality Engineer
Your main tasks
* 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 (automated measuring systems)
* 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 CAPAs, 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, etc.
* 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
* A minimum of a Bachelor's degree in Engineering or related technical or scientific discipline
* At least 7 years of experience in a related field in a Medical Device company is required
* Previous Quality Engineering experience and knowledge of material science and mechanical product knowledge is preferred
* Working knowledge of Design Controls, GMPs, QSR, 21 CFR 820, MDD 93/42/EEC, ISO13485 and ISO14971 is required
* Development and manufacturing experience is preferred
* Proven exceptional written and oral presentation skills
* Strong knowledge and skills in MS Office
* Excellent problem solving, decision-making, and root cause analysis skills
* Interpersonal skills that foster conflict resolution
* Ability to multi-task independently with minimal supervision
Assignment start: February 2019
Planned assignment duration: end of 2019
Workload: 100% (40h/week)
If you have the required experience and if you would like to apply for this interesting position, please send your complete application documents (CV, testimonials, diplomas) to nicole.blum(at)kellyservices.ch or apply online.
We are looking forward to getting to know you!