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Staff (Senior) Quality Engineer
Requisition ID: 1705615130W
"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 Credo
DePuy 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. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today’s evolving health care environment. Our broad array of inspired, innovative and high-quality offerings help advance the health and wellbeing of people around the world.
For the Quality Operations department in Hägendorf / SO, we are looking for a Senior Quality Engineer (f / m)
Under the direction of the Plant QA Manager and with the objective of maintaining high quality standards of the product manufacturing process and compliance with regulatory requirements, you will administer Quality Assurance support to Quality Operations of a complex site and/or demanding compliance profile. You will directly supervise Quality Engineers and Validation Engineers in day to day activities supporting all Business Units. You will ensure the site has adequate quality support, documentation review, and support projects, process and new product introductions or upgrading of existing processes and products and subsequent qualifications. Other tasks include:
- Ensures that the quality aspects for new processes, products and or upgrading of existing processes and products and subsequent PQ’s are met
- Supports/Initiates investigations for non-conformances
- Approves specification and process changes per applicable procedures
- Provides feedback to operations on problems related to quality and/or compliance
- Supports Operations in evaluation and implementation of actions plans to eliminate root causes of non-conformances
- Supports internal and external audit programs
- Promotes the use of Process Excellence tools to enhance analytical thinking and problem solving techniques
- Provides support to plant wide initiatives such as implementation of new initiatives safety, environmental and Quality related initiatives
- Supports and promotes the safety and industrial hygiene objectives of the plant
- Initiates and maintains interplant communications of quality issues
- Supports on-going continuing efforts and projects to improve our manufacturing Quality Systems, processes
- Supports and promotes cost savings opportunities that work toward global objectives in the organization
- Actively supports other plant functions in the implementation of company programs and projects
- Enforces, promotes and observes all safety, industrial hygiene rules and regulations established by the Company
- Is aware of, and complies with, Company policies on Safety
- Reports accidents, incidents, near misses, and hazardous situations in a timely manner and participates in the corrective action process
- University/Bachelor’s Degree or Equivalent in a Life Science, Engineering, or Physical Science area
- 6-8 of years related experience required
- Experience in the Medical Device environment with respective regulations knowledge will be preferred
- Process Excellence / Six Sigma Certification or equivalent preferred
- Good oral and written German and English language skills are required
If you are a creative and innovative mind passionate about medical technology and want to become part of a successful and growing organization, then please send us your online application (CV, Motivation Letter, Working References etc.)!
Synthes Produktions GmbH (7117)