Acclarent, a member of Johnson & Johnson's Family of Companies, is recruiting for a Principal Quality Engineer to be located in Irvine, CA.
Acclarent, Inc. is a medical device company, whose singular focus is to free patients to live better lives by designing, developing, and commercializing medical devices that address conditions affecting the ear, nose, and throat.
Acclarent, Inc. is aligned to the Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Devices sector within Johnson & Johnson, 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.
As a principal quality engineer, oversees the execution of the Quality plan for each product, ensuring product realization is conducted in compliance with internal, customer, and regulatory requirements during all phases of the product lifecycle.
As a statistical techniques Lead Subject Matter Expert (Lead SME), oversees the establishment and the implementation of statistical techniques and methodologies to support quality system analysis and decision making, including monitoring of trends and the establishment of triggers.
- Reviews new and modified product design and manufacturing processes for quality characteristics, including manufacturability, serviceability, testability, reliability and conformance to product and quality system requirements.
- Leads the product risk management process, including the development and maintenance of risk management files.
- Qualifies component and service suppliers, conducts supplier audits and ensures that appropriate supplier quality controls are implemented.
- Analyzes data and applies knowledge of engineering principles and practices to implement continuous improvement projects.
- Monitors internal and external standards changes related to quality engineering requirements and develops and implements compliance strategies.
- Provides guidance to R&D, Operations and Quality on design and production/process controls, risk management, root cause analysis, validation, and the application of statistical methods.
- Designs, selects, and applies appropriate statistical methods.
- Reviews the application of statistics commensurate with the risk.
- Owns the process of statistical techniques in their respective area.
- Creates and owns internal statistical technique training material for SME and functional area personnel.
- Other responsibilities as required or assigned by manager.
- Bachelor's degree in a life science, engineering, physical science or related discipline
- At least 8 years of experience as a Quality Professional in an FDA-regulated industry, with at least 5 years in the Medical Device industry
- In-depth knowledge of design control, risk management, production and process controls and applicable regulations (i.e., ISO 13485, FDA Quality System Regulation, ISO 14971)
- Working knowledge of and experience in the application of statistical methods
- Superior verbal and written communication skills and the ability to effectively communicate with internal and external personnel at all levels of the organization
- Graduate degree (i.e. Master, PhD or equivalent degree) in statistics or a related quantitative field with sufficient concentration in statistics, and/or equivalent experience in statistical applications and advanced statistical certification.
- Advanced degree in a life science, engineering, physical science, or related discipline
- Process Excellence/Six Sigma certification
- ASQ Certified Quality Engineer (CQE)
- ASQ Certified Reliability Engineer (CRE)
This position is located in Irvine, CA and may require some travel.
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Acclarent, Inc. (6206)Job Function
Quality (Eng)Requisition ID
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