Principal Design Quality Engineer – Sustaining Engineering

Job description

Principal Design Quality Engineer – Sustaining Engineering-00000Z34Beschreibung"Caring for the world… one person at a time” inspires and unites the people of Johnson & Johnson. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable CredoDePuy Synthes Companies of Johnson & Johnson is the largest, most comprehensive orthopedic and neurological business in the world. DePuy Synthes offer an unparalleled breadth and depth of technology, devices, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, cranio-maxillofacial, power tools and biomaterials. Our broad array of inspired, innovative and high-quality offerings help advance the health and wellbeing of people around the world.
For our Headquarters in Zuchwil, Solothurn we are looking for a highly committedPrincipal Design Quality Engineer – Sustaining EngineeringThe successful candidate will be responsible for managing Design Quality Engineers supporting Sustaining Engineering, Lifecycle Management and Base Business projects.
In this hands-on position, she/he should excel in an environment that embraces teamwork, change, risk-based decision making and flexibility.
Your major responsibilities
- Manage and develop team focused on sustaining engineering and life cycle management activities related to the business
- Enhance the related Quality System processes to better reflect state of the art practices and drive continuous improvement
- Support transfer to manufacturing activities both in Product Development and base business
- Conduct and lead process verification and validation activities
- Conduct and lead design / process failure mode effects and analysis
- Develop inspection methodology and acceptance criteria for inspection sample plans
- Work closely with suppliers on the qualification of new parts and processes supporting product development.
- Conduct assessments of new suppliers as required as a part of the project teams
- Provide leadership in all areas of the Quality System, including, but not limited to Corrective & Preventive Actions, Complaints, Post Market Surveillance, Nonconforming Materials, Risk Management, etc.
- Provide leadership in the understanding of medical device regulations to other disciplines. This candidate must be able to communicate effectively at all levels within Quality as well as cross functionally with departments such as PD, Regulatory, Manufacturing, and Marketing
- Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times
- Diligently participate in our compliance program-related activities as denoted by your supervisorQualifikationen
- A minimum BS degree in a Natural Sciences, Engineering or related technical discipline with a minimum of 7 plus years of experience in related field is required. A Master’s degree is a plus
- Management Experience
- Fluency in English, German basic
- Previous experience in a medical device or a healthcare discipline is strongly preferred
- Experience in implementing Design Excellence from concept to full implementation in a technical / R&D setting
- Strong working knowledge of QSR and ISO quality requirements is strongly preferred
- Strong quality engineering skills with a proven track record in design verification/validation, process verification/validation, and design/process failure modes and effects analyses is strongly preferred
- Blueprint literacy including GD&T preferred
- Knowledge of process and design excellence tools is strongly preferred
- Candidate should possess excellent problem solving, decision-making, and root cause analysis skills in addition to interpersonal skills that foster conflict resolution as it relates to technical situations
- This candidate should have a proven track record implementing Quality System improvements to meet compliance and overall business goalsIf you feel attracted by this challenge and want to be part of a successful and growing organization, then please send us your online application (CV, Motivation Letter, Working References etc.).Primärer Standort: Europa/mittlerer Osten/Afrika-Schweiz-Solothurn-ZuchwilOrganisation: Synthes GmbH (7111)Funktion: Quality