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 is anchored in the internationally applicable Credo. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. We have more than 260 operating companies in more than 60 countries employing approximately 134,000 people. Our worldwide headquarters is in New Brunswick, New Jersey, USA.
The Site Quality Source Engineer serves as the on-site Johnson & Johnson Medical Devices (JJMD) quality engineering representative for the Strategic Collaborator (SC). In collaboration with the SC, he/she utilizes quality engineering principles and problem-solving skills to improve and maintain JJMD products and processes. He/she supports the SC quality engineering team on initiatives impacting JJMD products and processes, by providing guidance in validation, risk management, product quality issue resolution and escalation, and quality systems performance monitoring. The Quality Source Engineer is responsible for ensuring that the SC has a clear understanding and ability to execute to the JJMD/SC Quality Agreement requirements, J&J Policies, and applicable regulations and standards.
- Reviews and approves key quality records related to JJMD products.
- Review and approved process validation, supplier validations and inspection plans.
- Coordinates JJMD review of Nonconformances/CAPAs in collaboration with SC and other required JJMD functions.
- Partner with SC in nonconformance investigationsSupports SC Quality and Manufacturing Engineering on the resolution of quality issues impacting JJMD products and coordinates additional subject matter expert support needed from JJMD.
- Support Employee certification and re certification processes for lot release technicians.
- Supports SC Quality and Manufacturing Engineering on the resolution of quality issues impacting JJMD products and coordinates additional subject matter expert support needed from JJMD.
- Supports improvement plans to address below-target metrics and negative trends.
- Supports SC on External Audit Readiness initiatives
Who we are looking for :
- Bachelor's Degree, preferably in Engineering or related technical field.
- Quality Engineering Certifications is an advantage
- Experience in Nonconformance and/or CAPA management is plus
- Experience in process/design validation, supplier validation and inspection plans are advantagesRelevant experience working in manufacturing/operations would be good
- Technical training or experience using Statistics, Lean and Six Sigma Methodologies is good to have
- English: Very good
- German: Good
This role based in Balsthal, Switzerland will initially be limited to approx. 9 months. If you are interested in working for a global leading health care company in a challenging role, then send us your application in English today. Or give us a call if you have any questions!
Randstad (Schweiz) AG, c/o Johnson & Johnson