Johnson & Johnson Careers
Senior Quality Engineer – Product Quality
Requisition ID: 0871180829
Advanced Sterilization Products is recruiting for a Senior Quality Engineer – Product Quality to be located in Irvine, CA.
Healthcare-associated infections (HAIs) have a devastating personal and economic impact, claiming the lives of 99,000 people in the U.S. each year at a cost of up to $45 billion. Ensuring that all surgical devices are properly sterilized is one-way healthcare workers can help reduce the incidences of HAIs, and Advanced Sterilization Products (ASP) has been partnering with hospitals for decades to safeguard patient health and safety. ASP has a strong track record of designing and delivering innovative infection-prevention solutions, from low-temperature steam sterilization to high-level disinfection, and is a global market leader setting the standard in sterilization.
Johnson & Johnson announced that it has received a binding offer from Fortive Corporation to acquire Advanced Sterilization Products(ASP). If the offer is accepted, the proposed transaction would be expected to close no later than early 2019, subject to customary closing conditions and regulatory approvals. Should you receive and accept an offer for this position, upon completion of the transaction, your employment with ASP will transfer to Fortive according to local law and will be governed by Fortive’s employment processes, programs, policies and benefits plans.
You, the Senior Quality Engineer – Product Quality will be responsible for:
- Subject matter expertise in requirements gathering, facilitating risk assessments, defining test strategies, and guiding project teams on design controls
- Provide constructive technical challenge to the design and development and lifecycle management of a capital systems from a product/system and process perspective.
- Providing Quality leadership on product project teams to ensure design & implementation of world-class quality engineering to support activities such as reliability, risk management, analytics/statistical techniques, requirements management, verification & validation, and design control being designed and validated to meet intended uses.
- Developing and executing the product Quality Plan, ensuring product realization is conducted in compliance with internal, customer, and regulatory requirements during all phases of the product lifecycle.
- Ensure that documented evidence exists to demonstrate a high degree of assurance that specific design and processes will consistently and continually produce a product that meets specifications and critical to quality attributes.
- Lead project teams by utilizing risk management process and tools; and effectively drives reasonable and appropriate risk controls.
- Provide support in Statistical Analysis for project teams.
- Lead complex investigations, coordinate technical teams to ensure sound experimental design, effective data analysis, risk analysis, design verification and validation and subsequent closure to technical investigations.
- Initiate and supports continuous process improvements within area of responsibility and conduct supplier quality system and product audits as needed.
- Support, perform, or oversee Internal and External Audits and CAPAs; be accountable for preparing and tracking Audit Finding Reports (AFRs) in response to observations from Internal and External Inspections / Audits to ensure compliance with Quality Management System elements.
- Provide backroom support for 3rd Party Inspections and Audits (e.g. Registrar, Notified Body, FDA, or customer audits).
- Serves as the technical expert for the organization (worldwide) in the application of advanced theories, concepts, principles, and processes for an assigned area of responsibility (i.e., subject matter, function, type of facility, or equipment, or product).
- Conduct or support failure and complaint investigations.
- A B.S. in Engineering with 4 or more years of related experience is required.
- A Master's degree in Engineering discipline plus 2 or more years of related experience and/or training; or Ph.D. in an Engineering discipline is preferred.
- Engineering experience in an FDA-regulated industry (medical device, pharmaceutical, etc.) and working knowledge of 21 CFR Part 820 and ISO 13485 is preferred.
- Understanding ISO 14971 and FDA Guidance and thorough understanding in the application of risk management tools, such as, Risk Analysis, FMEA and FTA is preferred.
- Experienced in applying statistical methods, creating sampling plans and sample size calculations, and using data analysis in support of objective decision making is preferred.
- Strong understanding of Design Control and medical device product development with working knowledge of product design verification, as well as product and process validation activities is preferred.
- A working knowledge of Statistical Analysis Software tools, such as, MiniTab, SPC Software, etc. is preferred.
- Working knowledge in using investigational tools, such as, Cause and Effect Diagrams, Process Optimization, Design of Experiments, Trend Analysis, Capability Analysis, Control Charts, Pareto Charting, etc. is preferred.
- Preferred experiences are: Quality Engineering (example: ASQ CQE, JJQE, etc.) and/or Process Excellence/Six Sigma Certifications (Green Belt, Black Belt)
- This position may require approximately 10% national and international travel and will be based in Irvine, California.
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.
Advanced Sterilization Products (ASP)