PROGRAM MANAGER, NEW PRODUCT DEVELOPMENT QUALITY

Johnson & Johnson is recruiting for a Manager, NPD Quality Engineering located in either Irvine or Santa Rosa, CA.
Remote working arrangements may be considered for this role.
At 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.
nj.
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Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion, we are proud to be an equal opportunity employer.
The Manager, NPD Quality Engineering is responsible for ensuring effective implementation of BWI New Product Development (NPD) processes, Product Sustaining Engineering, and continuous improvement and coordinates NPD quality strategy, objectives, and metrics to ensure business continuity focusing on delivery of safe and effective products meeting customer requirements and expectations in full compliance with all relevant regulatory requirements and applicable standards.
Under (e.
., limited supervision, general direction, etc.) and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position.
Manages NPD Quality functions, setting the priorities in accordance with program goals while meeting applicable regulatory requirements, BWI policies and procedures.
Team Member of New Product Development, continuous product enhancements and quality projects at Biosense Webster.
New Product Development Quality – Oversees directly and indirectly an organization of Quality professionals, such as engineers, technicians and scientists that focus on quality aspects of development, launching, lifecycle, manufacturing transfer and support.
Quality Services – supports business process and compliance, quality risk management, design assurance, external audits, corrective and preventive action, investigations, field actions and evaluations.
Partners with cross functional leaders from R&D, Supply chain, Medical, Clinical, RA, etc.
to drive risk mitigation, proactive action, and continuous improvement.
Promotes Quality vision and culture.
Recruits and retain high caliber Quality professionals.
Perform other work-related duties as assigned by the leader of this role.
Responsible for communicating business related issues or opportunities to next management level Responsible for ensuring that direct reports 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 A minimum of a bachelor’s degree is required.
• A minimum of 5 years of regulated products experience, with a minimum of 1 year in quality management or related functions.
• Excellent communication skills both written and oral.
• Knowledge of relevant applicable standards and regulations for new product development.
· Ability to interpret above standards and regulations and apply as an input to all company activities and management decisions.
· Ability to enroll and influence across functional areas internally and externally.
· Strong collaboration and influence management skills to partner effectively.
· High tolerance for ambiguity in a complex environment.
· Preferred.
An Advanced or master’s degree preferred.
Preferred Area of Study.
Life Sciences or Engineering field.
Experience in the Medical Device, Pharmaceutical, and/or Healthcare industry Excellent knowledge of quality Understanding of manufacturing systems and applicable regulations, i.
.
ISO , FDA's GMP and MDR requirements for medical devices and the ability to interact inspectors and auditors The anticipated base pay range for this position is $.
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 may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans.
For additional general information on company benefits, please go to.
- https://www.
areers.
nj.
om/employee-benefits For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.
areers.
nj.
om.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.