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
· 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.