Director, New Product Development (NPD CA) Quality Eng

DUTIES & RESPONSIBILITIES
In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• 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

Qualifications

EXPERIENCE AND EDUCATION
• A bachelor's degree in science, engineering, biology, chemistry or related technical field is required.
• Master's degree in science engineering is preferred.
• A minimum of 10 years of related experience, including experience working in pharmaceutical, consumer, medical device or other highly regulated industry.
• Experience in Electrophysiology and Interventional Cardiology field is highly preferred.
• Previous Quality Engineering Design and Process Development experience (Core Team Level) is required including but not limited to: Risk and Requirements Management, Planning and execution of the verification and validation activities for Class II and III Devices.
• 7+ years of experience managing both technical and non-technical staff.
• Proven leadership in developing and coaching staff is required.
• Advanced critical thinking and investigation skills are required.
• Employee must be able to effectively prioritize and manage multiple activities and responsibilities.
• Strong written and verbal communication skills are required.
• Developed presentation skills.
• Professional demeanor on the phone and in email is required.
• Strong attention to detail is required.
• Ability to learn and manipulate complex computer system applications is required.
• Knowledge of applicable medical device regulations is required (21 CFR 820, Medical Device Directive, EU Medical Device Regulation, ISO60601, IEC62304, etc.)

OTHER
• An advanced Degree in Engineering, Biology, Chemistry or related technical field is preferred.
• Familiarity of the devices used during a typical A-fib case, is highly desirable. Clinical workflow knowledge is a plus.
• Knowledge of Good Manufacturing Practice, Good Laboratory Practice and/or Good Clinical Practice is desirable.
• Experience leading other verification/validation engineers or contractors.
• Domestic and international travel may be required.

The anticipated base pay range for this position is 146000 to 251850.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible to participate in the Company's long-term incentive program.
• Employees are eligible for the following time off benefits:
o Vacation - up to 120 hours per calendar year
o Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
o Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
• Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.