Senior Design Quality Engineer - JNJKJP00035767 (m/f/d)

REFERENCE NUMBER:

410478/29

MY DUTIES:

-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 for clear definition of project scope and deliverables, milestones and timeline, project risks and contingency plans

MY QUALIFICATIONS:

-Bachelor’s degree in Engineering or a related technical or scientific discipline with profound and in-depth experience in a related field
-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
-Experience in an Medical Device regulated environment
-Strong MS Office knowledge and skills
-Excellent problem solving, decision-making, and root cause analysis skills
-Interpersonal skills that foster conflict resolution
-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

MY BENEFITS:

-A very renowned company
-A highly motivated team and an open way of communication
-You will work in an international environment

PROJECT INFORMATION:

As a modern company, our client manages to constantly develop further and break new ground.

ABOUT HAYS:

With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.