Johnson & Johnson Karrieren
Site Quality Source Technician (m/w/d)
Requisition ID: 1905736819W
Johnson & Johnson, through its operating companies, is the world's most comprehensive and broadly-based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. We strive to provide scientifically sound, high quality products and services to help heal, cure disease and improve the quality of life
The Site Quality Source Technician is responsible for the execution of the Product Release Certification and Monitoring program for JJMD (Johnson & Johnson Medical Devices) products manufactured by the Strategic Collaborator (SC). He/she ensures that the SC has a clear understanding and the ability to execute against JJMD’s product release requirements.
Main Responsibilities & Duties:
- Executes the Lot Release Certification and Monitoring Program for JJMD products according to established procedures.
- Training of SC personnel performing product release of JJMD sterile and non-sterile products as part of the Certification Program.
- Perform certification, re-certification, and decertification of SC product release personnel.
- Monitor SC’s product release performance through the review of a sample of Device History Records (DHR) in accordance to approved sampling plans.
- Develop work plans to meet certification and monitoring weekly requirements including any necessary adjustments based on production schedules, holidays, and sampling plan revisions.
- Generate Nonconformance Reports (NCR) resulting from the product release monitoring process as per applicable approved procedures. Partnerships with the SC on the timely resolution of product release monitoring related NCRs and any other discrepancies found during the DHR monitoring process.
- Track lot release certification and monitoring data in order to measure program effectiveness and to identify trends. Report data analysis, including any negative trend, to his/her direct supervisor.
- Bachelor´s degree in Quality management or engineering preferred.
- 3- 5 years of related experience.
- Strong communication skills, quality-oriented mindset & team player.
- Independence, flexibility, attention to detail and service minded are required.
- Fluent in German and good English skills.
Synthes Tuttlingen (7131)