Johnson & Johnson Careers
Quality Engineer 1
Requisition ID: 1396180612
Advanced Sterilization Products Inc., a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Quality Engineer 1 position located in Irvine, CA.
ASP (Advanced Sterilization Products), a member of the Johnson & Johnson Family of Companies, is a leading designer and developer of innovative instrument sterilization, high-level disinfection and cleaning technologies. The company is dedicated to providing infection prevention solutions that create the safest possible environments for patients, healthcare providers and communities. ASP is based in Irvine, California with offices around the world. For more information, please visit www.aspjj.com or follow us at www.Twitter.com/aspjj.
The Quality Engineer I under general supervision will be responsible for providing support to ASP products manufactured at the Irvine Facility. This role will support base business production operations, and effective transfer of new products into production. Responsible for supporting and/or leading effective and efficient Quality Engineering Techniques such as risk analysis, test method development, implementation of sampling plans, and determining verification and validation strategies. This role will lead and/or support root-cause investigations as it relates to non-conforming product and quality events on the production floor.
- Under general supervision will provide quality expertise/guidance on manufacturing processes for Consumable Medical Devices and will be knowledgeable of non-conformance systems and of the requirements for first article inspection, incoming, in process inspections, and lot release testing, including sampling strategies and test methods.
- Provide expertise on FDA Quality Systems regulations, and ISO 13485.
- Perform process variability studies, risk analysis and test method variability, will review and approve validation and qualification protocols and support the execution of process / product qualifications & validations (IQ, OQ, PQ).
- Provide support to develop and maintain documentation to support the validation process, specifications, manufacturing and test procedure and will participate and collaborate with supply chain, R&D engineering, operations engineering and manufacturing to identify potential areas of process variability, address root causes and implement improvements.
- Provide technical QA support to assigned inspection and manufacturing area(s).
- Perform other duties as assigned by the manager.
- A Bachelor’s Degree in Engineering, Life Sciences, or related field of study is required.
- 1-2 Years of related work experience
- Experience with root cause investigations, non-conformances, data analysis, and FMEAs is required.
- Experience using MS Excel and PowerPoint is required.
- Experience in a FDA regulated environment preferred.
- Experience with Medical Devices highly desired.
- Quality related certifications or trainings is preferred.
- Experience with SAP, EtQ, and MiniTab preferred.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Ethicon Inc. (6045)