Staff Quality Engineer – Product Quality

The Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Devices sector within Johnson & Johnson, is recruiting for a Staff Product Quality Engineer, Product Quality aligned to Advanced Sterilization Products (ASP), division of Ethicon, 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.

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 or follow us at

You, the Staff 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 (Electrical or Biomedical Engineering or equivalent) with 6 or more years of related experience is required.
  • A Master's degree in Engineering discipline plus 4 or more years of related experience and/or training; or Ph.D. in an Engineering discipline and 2 or more years is preferred.
  • Strongly preferred emphasis in Electrical Engineering or related experience and/or training.
  • Engineering experience in an FDA-regulated industry (medical device, pharmaceutical, etc.) and working knowledge of 21 CFR Part 820 and ISO 13485 is preferred.
  • Ability to provide an expert knowledge of both regulatory requirements and other compliance areas to minimize risk across franchise is required.
  • Strong understanding of appropriate Risk Management regulations and guidance standards is required.
  • 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 is preferred.
  • Strong Quality Engineering skills with working knowledge of product design verification, as well as product and process validation activities is required.
  • Excellent written and verbal communication skills and capable of working independently and in a team setting and has the ability to work and communicate in a cross-cultural environment is required.
  • Lead a high performance project team and drive performance results and work with core teams and development partners to ensure robust design quality practices are embedded and applied is required.
  • Lead continuous improvement of the new product development and lifecycle management processes and procedures is required.
  • A working knowledge of Statistical Analysis Software tools, such as, MiniTab, SPC Software, etc. is required.
  • Leadership ability in using problem solving techniques including root cause analysis and cause and effect analysis is required.
  • 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 required.
  • Leadership ability in developing high-quality product reliability requirements for products in partnership with various departments, such as, R&D, product management, Service etc. and monitoring the implementation and execution of these reliability goals is required.
  • Ability to effectively utilize knowledge of Qualitative Reliability Techniques (such as dFMEA, pFMEA, DFx); Environmental Qualitative Reliability Tests (HALT and HASS) and Reliability Prediction and Ongoing Reliability Test (ORT) are 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.

Primary Location
United States-California-Irvine
Ethicon Inc. (6045)
Job Function
Quality (Eng)
Requisition ID