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Senior Quality Engineer - Cerenovus (1 of 2)
Requisition ID: 6782171211
Johnson & Johnson’s Neurovascular Division (CERENOVUS), a member of the Medical Device group within Cardiovascular & Specialty Solutions (CSS) is recruiting for a Senior Quality Engineer - Cerenovus. The position is located in Los Gatos, CA.
The Cardiovascular & Specialty Solutions (CSS) Group consists of six diverse businesses aside from Neurovascular which serve a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology (EP), Surgical and Non-Surgical Aesthetics, and Reprocessing.
Johnson & Johnson’s Neurovascular (CERENOVUS) Division is one of the leaders in the medical device industry. Our implants and instruments are used by interventional neuroradiologists, neurosurgeons and neurologists, to treat patients with conditions resulting from hemorrhagic and ischemic stroke. Our environment is entrepreneurial, learning-driven, and is as challenging as it is rewarding. We are one of the fastest growing businesses within Johnson & Johnson.
You, The Senior Quality Engineer - Cerenovus will support the development and maintenance of Cerenovus products manufactured at the Los Gatos 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 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.
- Provide their expertise and experience with general manufacturing processes for 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.
- Be proficient in the understanding of regulatory requirements for medical devices and will demonstrate proficiency with, process capability analysis, FMEA, analysis.
- 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).
- 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.
- 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.
- Provide technical QA support to assigned inspection and manufacturing area(s).
- 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.
- Other duties and responsibilities as needed/assigned by the manger.
- A Bachelor’s degree and a minimum of 4 years’ experience in medical device manufacturing or related industry experience is required.
- A technical degree in Chemistry, Mechanical Engineering, Bio Engineering, or related scientific /technical field is preferred.
- Interpersonal skills to work in cross functional teams are required.
- Planning and organizational skills are required.
- Computer literacy, knowledge of MS Office, statistical programs is required.
- Quality engineering skills such as: statistical analysis, Statistical Process Control validation and verification, GRR, process validation, DOE and risk management (e.g., FMEA), biocompatibility, sterilization, packaging studies, labeling requirements are strongly preferred.
- Knowledgeable with industry standards, QSR FDA 820, ISO 13485 medical device requirements and IS0 14971 are required.
- Prior experience in an internationally regulated environment required.
- Prior experience in ISO 13485 and/or QSR 820 FDA regulated environment is required.
- Process Excellence/Six Sigma/Lean experience and/or certification is preferred.
- Experience working with cross functional teams such as Engineering, Operations, Supply Chain, Suppliers, New Product Development etc. is required.
- Experience with reading and interpreting mechanical drawings is preferred.
- Any quality related certifications or trainings are preferred.
- This position will be located in Los Gatos, CA and may require up to 10% domestic and/or international travel.
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.
United States-California-Los Gatos
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