Program Manager, New Product Development Quality
Company: J&J Family of Companies
Location: Irvine
Posted on: May 4, 2024
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Job Description:
Program Manager, New Product Development Quality -
2406185660W
Description
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.jnj.com/.
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.g., 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 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.e. ISO 13485, 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 $99,000 -
$170,200. 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.careers.jnj.com/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.careers.jnj.com .
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.
Primary Location NA-US-California-Irvine
Organization Biosense Webster Inc. (6010)
Travel Yes, 25 % of the Time
Job Function Quality Assurance
Req ID: 2406185660W
Keywords: J&J Family of Companies, Palm Desert , Program Manager, New Product Development Quality, Executive , Irvine, California
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