The CSS Group consists of six diverse businesses including Acclarent, Advanced Sterilization Products (ASP), Biosense Webster (BWI), Cerenovus, 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.
You, the Director, Quality NPD will be responsible for the ASP NPD, and Life Cycle Management (LCM) Quality (sustaining engineering support) 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. Quality responsibilities for this role include elements of: Strategic Planning, NPD Quality Planning, Software Quality, Product Quality Assurance, Change Control, Quality Systems, Compliance, Quality planning (budgeting, organization resources and inspection strategy) and Quality Process Excellence.
- Be responsible for compliance aspects as applicable to New Product Introduction, Software Quality and Life Cycle Management Quality
- Establish and manage all Quality Assurance systems required to support Life Cycle Management Quality (Life Sciences) / Sustaining Engineering Quality worldwide for ASP including: Quality Planning and Quality Engineering
- Ensure Design Validation and Verification Complianc
- Design Quality Systems and Compliance (Change Control, CAPA and Internal Audits) Design and Development Planning
- Escalation and Investigation of Product Quality Issues
- Coordinate BULT (Business Unit Leadership Teams) Management Reviews and quality engineering support
- 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
- Be responsible for supporting site inspection readiness program.
- Be responsible for site NPD, Software and LCM Quality Budgets and for the identification and implementation of cost improvement initiative to drive efficiencies without compromising compliance.
- Define & monitor LCM Quality, QS and Compliance metrics to drive product and system quality improvements. Responsible for the success of achieving functional strategies and objectives.
- Develop policies and requirements for LCM Quality that optimize compliance and decrease risk while maintaining and effective and efficient supply chain.
- Approve and direct the implementation of LCM Quality System improvements, standards and policies in alignment with Global Quality Operations and Franchise QRC.
- Evaluate capabilities against industry standards and regulatory expectations; applies technical, business and compliance knowledge to improve results
- Provide coaching and staff development, including performance management and talent development.
- A bachelorâs degree and a minimum of 10 years of relevant work experience is required.
- A minimum of 5 years managerial experience with demonstrated people development and leadership skills is required.
- A technical degree in Engineering, Life Science or Management is preferred.
- A minimum of 10 years of experience in medical device regulatory, quality compliance, or product quality is preferred.
- Experience with new product development is required.
- Knowledge of regulatory and business strategies to improve compliance profile is required.
- Knowledge of Quality System Regulation 21 CFR 820 and ISO 13485 Standard is required.
- 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. Influence, interpersonal and communication skills are required.
- Conflict resolution skills and organizational management skills are required.
- Business ethics Analytical reasoning ability is required.
- Computer literate required.
- Extensive experience in FDA QSR, ISO, MDD and CMDR regulations with knowledge of global adverse event reporting requirements is preferred.
- Operations or R&D experience in a medical device setting is preferred.
- This position will be located in Irvine, CA and may require up to 10% domestic and/or international travel.
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.
Ethicon Inc. (6045)
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• Post ID: 160499242 la