Senior Quality Engineer New Product Development

  • Company: Johnson & Johnson
  • Posted: March 14, 2017
  • Reference ID: 3987170306-en-us

Advanced Sterilization Products, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Quality Engineer - New Product Development / Lifecycle Manager, located in Irvine, CA. 


Advanced Sterilization Products (ASP), a member of the Johnson & Johnson Family of Companies, is a leading designer and developer of innovative instrument sterilization and high-level disinfection 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.


The Senior Product Quality Engineer will be responsible for:


·         Providing Quality System Regulatory interpretation, consulting, training, and assessment to ensure product teams are aligned with current regulatory requirements, standards, and current industry trends.

·         Lead project teams to utilize risk management and process excellence tools and effectively drives reasonable and appropriate risk controls.
·         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.
·         Provide constructive technical challenge to the design and development of a product or process to drive better product or process performance and project outcomes.
·         Provides guidance on data analysis and statistical tools to conduct or support of trend analysis, root cause analysis, failure investigation, and risk assessment
·         Ensure the Safety and Reliability requirements for the products and provides leadership in driving to full implementation of requirements.
·         Ensure that documented evidence exists to provide 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.
·         Initiate and supports continuous process improvements within area of responsibility, and conducts supplier quality system and product audits as needed.
·         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).
·         Support, perform, or oversee Internal and External Audits and CAPAs 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 subject matter and expert and communicates to auditors and investigators.
Collaborate with core teams and development partners to ensure robust design quality practices are embedded and applied.


  • A minimum of a Bachelors of Science degree in Mechanical or Electrical Engineering or equivalent technical field is required
  • A minimum of 4 years of R&D engineering, Operations engineering or Quality or a similar technical field is required.
  • An advanced degree is preferred.
  • Experience within a FDA or highly regulated industry with understanding of 21 CFR Part 820, ISO 13485 and ISO 9001 is preferred.
  • Experience with risk management is required.
  • Strong understanding of appropriate Risk Management regulations and guidance standards, such as, ISO 14971 and FDA Guidance and thorough understanding in the application of risk management tools, such as, Risk Analysis and FMEA is preferred.
  • A degree and or proven work experience with applying statistical methods (applied statistics, sample plans and data analysis) to object decision making is preferred.
  • Working knowledge of product design verification, as well as product and process validation activities is preferred. 

  • Experience with problem solving techniques in root cause analysis is preferred.
  • Excellent both written and verbal communication skill and capable of working independently and in a team setting. Ability to work and communicate in a cross-cultural and cross-functional environment is required. 

  • Six Sigma/Process excellence or ASQ Certification is preferred. 

  • Project Management Certification or equivalent is preferred.
  • This position will be located in Irvine, CA and may require up to 10% of both domestic and international travel.

  • BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies

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

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