Director, New Product Development (NPD CA) Quality Eng

Company: Disability Solutions
Location: Irvine
Posted on: February 8, 2025

Job Description:

Johnson & Johnson is currently recruiting for a Director, New Product Development (NPD CA) Quality Eng located in Irvine, CA.\rAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.\rJOB SUMMARYThis position will have responsibility for leading, planning, execution, standardization and management of the NPD and related LCM policies, processes, and standards across the BWI Franchise.\rDUTIES & RESPONSIBILITIESIn accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

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• The Quality Engineering Director will be responsible for the BWI Quality Engineering functions as well as the quality system and compliance aspects related to this function.
• Initiates 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, Product Quality Assurance, Quality Systems, Compliance, Quality planning (budgeting, organization resources and inspection strategy) and Quality Design/Process Excellence for both the new products and existing legacy products.
• Collaborating with the management of all day-to-day Quality Engineering activities to support worldwide production and spare parts activities related to new product introduction which includes: Quality Control Acceptance Inspection; Production & Process Control; Quality Engineering; Ensuring Process Validation and Verification Compliance; Plant Quality Systems and Compliance as applicable to Supply Chain; Plant Quality Laboratories; Calibration and Preventive Maintenance Program; Quality Operations activities; Escalation and Investigation of Product Quality Issues; Coordination of data to support site Management Reviews.
• Responsible for the harmonization activities of QE activities related to NPD within BWI and as applicable to CSS Groups.
• 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; NPD Quality Liaison between BWI Franchise Quality and Supply Chain Quality for sites globally.
• Drive collaboration amongst the various NPD Departments in order to promote Design Excellence and promote quality improvements within new and existing products.
• Responsible for supporting and driving the on-going innovation at BWI for the NPD product lines as it relates to the Quality Engineering contributions.
• Define & monitor Quality Engineering, QS and Compliance Departments metrics to drive product and system quality improvements.
• Responsible for providing quality data inputs into the site management review process.
• Responsible for the success of achieving functional strategies and objectives.
• Develops policies and requirements for Quality Engineering that optimize compliance and decrease risk while maintaining and effective and efficient supply chain.
• Collaborates, directs and approves and the implementation of Quality System improvements standards and policies in alignment with Global and Franchise Quality requirements.
• Evaluates capabilities against industry standards and regulatory expectations; applies technical, business and compliance knowledge to improve results. Provides coaching and staff development, including performance management and talent development.
• Participant/ contributor of the Issue Escalation Process may be delegated voting rights from Senior Leadership.
• Collaborates with the Regulatory Affairs, Research and Development (R&D), Medical Safety, Medical Affairs, Manufacturing, Clinical/pre-Clinical, New Product Development (NPD) Teams and other departments to ensure compliance with applicable standards.
• Represents the products and processes during Regulatory Notified Body site visits.
• Providing updates to Sr. Management on the various activities within the represented QE Departments.
• Provides management direction, motivation, and support for department personnel.
• May be responsible for management of employees or contractors at remote work sites.
• Ensures that each staff member has clearly established goals and objectives, monitors staff performance, conducts periodic performance evaluations and compensation planning, and ensures succession planning for key positions, including own.
• Develops, coordinates, and otherwise ensures appropriate training for associates.
• Ensures individualized developmental plans are in place for all associates
• Responsible for communicating business related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed\r\r

Keywords: Disability Solutions, Irvine , Director, New Product Development (NPD CA) Quality Eng, Engineering , Irvine, California