Beschreibung
Design Quality Engineer: GMP, Medical Devices, Pharmaceuticals
A world renowned pharmaceutical and medical device manufacturer is seeking a Design Quality Engineer to work onsite in the manufacturing plant in Oberdorf, Switzerland.
POSITION DUTIES & 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.
* Additional duties as assigned.
PROFESSIONAL EXPERIENCE 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 an Medical Device regulated environment
Experience
OTHER REQUIREMENTS:
* 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.
Minimum Language required:
* Fluency in English is required, good knowledge of German would be a strong asset.