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QA DIRECTOR, NPI-8780130523


Advanced Sterilization Products Division of Ethicon, Inc., a member of Johnson & Johnson's Family of Companies, is currently recruiting for a QA Director, NPI (New Product Introduction), located in Irvine, CA.

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

Responsible for the ASP NPI Quality and Software Quality function as well as the quality system and compliance aspects related to this function. Initiate and/or supports innovative activities associated to product quality, quality system and compliance, establishes priorities and facilitates resource allocation.

The QA Director, NPI is responsible for defining leading, and implementing state-of-the-art quality engineering, human factors, statistical, and reliability programs focused on the design and development of all ASP products, leading/supporting quality and compliance activities for product transfer, as well as coordinating quality and risk management activities in support of new product development. Responsibilities for this role include elements of: Strategic Planning, NPI/Product Quality Assurance, Validation, Software Quality, Quality Systems, Compliance, Quality planning (budgeting, organization resources and inspection strategy) and Quality Process Excellence.

Other primary responsibilities of this role include to establish and manage all Quality Assurance systems required to support New Product Introduction and Software Quality worldwide for ASP including Product Risk Management, NPI Quality Planning, Software Quality: Product Software, Non-product Software and Enterprise Systems, Quality Engineering, Ensuring Design Validation and Verification Compliance, design Quality Systems and Compliance (Change Control, CAPA and Internal Audits, Design and Development Planning. Also escalation and Investigation of Product Quality Issues, and coordination of BULT (Business Unit Leadership Teams) Management Reviews and quality engineering support, and to participate and collaborate with Supply chain, R&D Engineering, Operations Engineering and Manufacturing leaders to identify potential areas of process variability, address root causes and implement improvement and post Market Surveillance. This role is also responsible for compliance aspects as applicable to NPI and Software Quality; is responsible for supporting site inspection readiness program, responsible for site NPI/Software Quality Budget and for the identification and implementation of cost improvement initiative to drive efficiencies without compromising compliance. Also, define & monitor NPI and Software Quality, QS and Compliance metrics to drive product and system quality improvements. Responsible for the success of achieving functional strategies and objectives. Develops policies and requirements for NPI /Software Quality that optimize compliance and decrease risk while maintaining and effective and efficient supply chain. Approves and directs the implementation of NPI / Software Quality System improvements, standards and policies in alignment with Global Quality Operations and Franchise QRC. Evaluates capabilities against industry standards and regulatory expectations; applies technical, business and compliance knowledge to improve results


A BS, Degree in Engineering or Life Science, Management required; advanced degree desired. 5+ years managerial experience with demonstrated people development and leadership skills required. 10+ years experience in medical device environments is required, capital equipment preferred. Knowledge of regulatory and business strategies to improve compliance profile is required.

Expert knowledge of medical device design controls and general Quality System Regulation (21 CFR 820), and ISO 13485 Standard is required. The Ability to effectively negotiate and influence upper management, regulatory agencies, and industry to ensure compliance with regulatory and business needs is required. Ability to work and communicate in a cross-cultural environment is required. Excellent communication skills both written and verbal are required.

Computer literacy is required.

10+ years experience in Quality, R&D, Design control or a related field is required.

Extensive experience in FDA QSR, ISO, MDD and CMDR regulations with knowledge of global adverse event reporting requirements is preferred.

Comprehensive product, process, and software validation experience in a medical device setting is preferred.

This position is located in Irvine, CA and may require up to 10% travel.

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Primary Location: North America-United States-California-Irvine
Organization: Advanced Sterilization Products (ASP)

Job : Quality Assurance

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