The Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Devices sector within Johnson & Johnson, is recruiting for a Quality Engineer II – Plant Quality aligned to Advanced Sterilization Products (ASP), located in Irvine, CA.
The CSS Group consists of six diverse businesses including Acclarent, Advanced Sterilization Products (ASP), Biosense Webster (BWI), Codman Neuro, Mentor, and Sterilmed. The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology (EP), Neurovascular and Neurosurgery, Surgical and Non-Surgical Aesthetics, and Reprocessing.
Advanced Sterilization Products (ASP), a Johnson & Johnson company, truly makes a difference by Protecting Lives against Infection. ASP has been innovating since 1987 to help healthcare facilities protect patients with best-in-class infection prevention solutions. Learn more about Advanced Sterilization Products at www.aspjj.com/us
The Quality Engineer II will support the development and maintenance of ASP products manufactured at the Irvine Facility.
· This role provides Quality Engineering support for base business production operations, and effective transfer of new products into production.
· Responsible for leading effective and efficient Quality Engineering Techniques such as risk analysis, test method development, and implementation of sampling plans, and determination of verification and validation strategies.
· This role will lead and or support root-cause investigations as it relates to non-conforming product, quality events on the production floor and CAPA.
· She/He will provide their expertise and experience with general manufacturing processes for Medical Device Capital Equipment or 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.
· She /He will provide expertise on FDA Quality Systems regulations, and ISO 13485.
· The individual will be proficient in the understanding of regulatory requirements for medical devices and will demonstrate proficiency with, process capability analysis, FMEA, analysis.
· She/ He will, be able to 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).
· The Engineer will 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.
· She/He will possess leadership skills and will be responsible for resolving Manufacturing and or Supplier related issues of ASP products and will devise and implement methods and procedures for inspecting, testing and evaluating production.
· She/He will provide technical QA support to assigned inspection and manufacturing area(s).
· The Senior Quality Engineer will participate in process evaluations (e.g. FMEA's), develop and execute manufacturing process valuations, will determine appropriate sampling plans for subsequent routine production and will participate in the training of new and lower level quality engineers.
This position requires:
· Minimum of 2 years related experience OR a minimum of a MS degree with a minimum of 1 years related experience OR a PhD with a minimum of 0 years related experience is required.
· Preferred areas of study include: Electrical Engineering (EE), Mechanical Engineering (ME), Chemical Engineering or related engineering, or Microbiology/ Chemistry.
· Experience with non-conformances is required.
· Experience FMEAs, and CAPAs is required.
· Working knowledge of first article inspection, in-coming/ in-process inspections, lot release testing and sampling plans required.
Preferred Elements Include:
· Experience in a FDA regulated environment preferred.
· Experience with Medical Devices highly desired.
· Prior experience with FDA audits would be a plus.
· Experience working with cross functional teams such as Engineering, Operations, Supply Chain, Suppliers, New Product Development etc, is desired.
· Experience with reading and interpreting mechanical drawings preferred.
· ASQ Certification is a plus.
· This position is located in Irvine CA, and may require some travel.