The CSS Group consists of six diverse businesses including Advanced Sterilization Products (ASP), Acclarent, Biosense Webster, Mentor, SEDASYS® and Sterilmed. The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology, Surgical and Non-Surgical Aesthetics, Sedation and Reprocessing. The CSS Group is committed to delivering innovative products, solutions and programs to address unmet customer and patient needs around the world. Our customers and the patients they treat are our first priority and these values are reflected in Our Credo, which guides our daily decisions and actions. Our relentless commitment to Quality and the principles that define us in Our Credo have helped us achieve significant milestones and continues to help us deliver significant growth year after year.
This position is specific to Advanced Sterilization Products.
The Staff Quality Engineer will:
- Establish and maintain quality assurance standards which adhere to Johnson and Johnson Quality requirements.
- System Requirements (21 CFR 820) and ISO regulations (ISO 13485) to ensure products and services are provided to customer requirements
- Be responsible for the quality and regulatory compliance of products manufactured at Suppliers and External Manufacturers
- Monitor quality performance of component suppliers and external manufacturers
- Establish inspection and test methods for assigned product lines manufactured at suppliers. Participate in technical assessments & quality system audits of suppliers to identify potential areas of risks, process variability and address root causes
- Perform process variability studies, Risk analysis, test method variability and establish sampling plans
- Lead or support teams to investigate supplier and external manufacturing quality issues (Failure investigations) to resolve complaints, non-conforming products and CAPA
- Lead the preparation of validation and qualification protocols and support the execution of supplier and external manufacturing process /product qualifications & validations (IQ, OQ, PQ) projects.
- Management of Supplier Change Notifications with suppliers and external manufacturers.
- 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
- Participate in preparation of Process/Design Failure Mode and Effects Analysis (PFMEA / DFMEA)
- Participate in new product development team activities in the development and qualification of suppliers
- Update plant staff on supplier quality metrics and performance at the Management Review of the Quality System and the Management Review Board. Compiles and recommends data driven conclusions for Management Review.
- Perform other work-related duties as assigned by the manager of the role.
- This position requires a minimum of a Bachelor of Science degree in Electrical Engineering (BSEE) or Mechanical Engineering (BSME) or Chemical Engineering (BSCE), or a related technical field.
- A minimum of 7+ years of experience in Quality Engineering or Quality Assurance, including data analysis, risk assessment and risk mitigation is required.
- Prior experience within an electro-mechanical environment is preferred.
- A Six Sigma Green belt /Black belt certification is preferred.
- Prior knowledge of medical device regulations such as 21 CFR 820 and ISO 13485 is preferred.
- Experience with process validations and the use/application of statistical tools is preferred.
- Knowledge of Non-Conformance Reports (NCRs) and Corrective and Preventive Action (CAPA) is preferred.
- Prior experience in sampling, design of experiments, process capability analysis as well as the capability to review manufacturing processes like control plans, process control and quality control is highly desired.
This position is located in Irvine, CA and may require up to 30% travel, international and domestic.
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Advanced Sterilization Products (ASP)Job Function
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