Caring for the world, one person at a time... inspires and unites the people of Johnson & Johnson. 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.
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. Our broad array of inspired, innovative and high-quality offerings, help advance the health and wellbeing of people around the world.
The Quality Source System Analyst drives the execution of Quality Systems (QS) at regional level, including Joint Quality Review (JQR), Metrics reporting, Tactical Reports, Data Trending, Records Archival, Training Completion Reports, QS Improvement Projects to ensure systems meet all business and regulatory requirements.
- Retrieves CAPA and Nonconformance data from QMS and calculates metrics in accordance to work instructions and complies with the Quality Agreement
- Supports on-site timely collection of Quality System data and metrics (i.e. NC, CAPA, Audit Observation, Stop Shipment, Escalation, Confirmed Manufacturing Complaint)
- Coordinates the finalization of different dashboards and supports the sites in the definition of comments and actions for metrics excursions and/or negative trends
- Builds and formats the final dashboards and presentations for various reporting tiers
- Assists and guide Site Liaisons and Source Quality Engineers with evaluation of data and creation of JQR slides
- Creates a tactical report to ensure an on-time completion of QS tasks within the organization
- Evaluates trends in QS (i.e. Escalations, Stop Shipments, Complaints) and collaborates with the Site Liaison to communicate to SC to identify mitigation actions
- Retrieves training certificates from Learning Management System (LMS) to prove training completion for equivalent training modules/content in JJMD and SC LMS
- Maintains QS tools and trackers
- Supports and coordinates Quality Source Systems Improvement Projects to enhance the efficiency with core responsibilities
- Supports (as required) the sites in the Change Management Process with providing guidance in ADAPTIV and Agile PLM system
- Serves as a Quality Source SME for ADAPTIV PLM and coordinates Change Orders (CO) for Quality Source owned documents
- Coordinates the continuous records archival as per standards and work instructions including the transfers of records from the site to Zuchwil, the preparation of the Quality Records Inventory List (QRIL) and the final archival with the service provider
Who we are looking for
- A minimum of a Bachelor's degree in Engineering, an Applied Science or a related technical and quality field is required
- Additional Quality System training is preferred
- Certification in PLM, ERP or other Quality Systems is preferred
- European Computer Driving License (ECDL) or equivalent is preferred
- At least 2-4 years professional work experience in Quality Engineering or Quality Assurance, including data analysis is required
- Very Good English skills
This role based in Zuchwil, Switzerland will initially be limited to approx. 12 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