SR QUALITY ENGINEER, NEW PRODUCT DEVELOPMENT (NPD)

Biosense Webster Inc, a member of Johnson & Johnson Family of Companies, is recruiting for a Sr Quality Engineer, New Product Development (NPD) to be located in Irvine, CA.
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.
om/.
The Sr Quality Engineer, New Product Development (NPD), performs quality assurance activities intended to ensure effective product quality processes are in place and executed throughout lifecycle of product.
Involved in New Product Development (NPD) teams and other activities to develop products, design verification tests, process validations and quality processes to ensure compliance with the company’s Quality System policies and procedures and applicable external requirements and standards.
As needed, assists to develop quality-engineered systems and products, and support qualification and validation activities.
Will show leadership in driving program/projects and innovating compliant approaches and solutions to problems.
If you are and individual who enjoys working with the other team members and changing the lives of our patients around the world come join our team at Biosense Webster! Key Responsibilities.
Lead and assist in NPD projects.
Assist in the development of effective quality control, design verification testing and associated risk documents.
Partner with other functional groups, including R&D and Operations in support of engineering projects, quality activities, and lifecycle management.
Provide support in quality improvement opportunities as appropriate to legacy products, continuous improvement and customer satisfaction.
Understand the corrective and preventive action process and process of investigating nonconformances, identifying root cause and recommending action.
Generates nonconformance reports and assists in investigation, final disposition and corrective action.
Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE).
Assigns/reviews quality inspection testing and test data.
Supports audits.
Review and/or approve process and product validation protocols and reports, equipment qualifications, engineering change orders.
Makes decisions independently on engineering problems and methods and represents the organization in conferences to resolve important questions and to plan and coordinate work.
Responsible for communicating business related issues or opportunities to next management levels.
Performs other quality related responsibilities as needed.
Qualifications Education.
University/Bachelor’s degree or equivalent is required.
Focus degree in Engineering and/or scientific field is preferred.
Experience and Skills Required.
A minimum of four (4) years of experience in a Medical Device or regulated industry.
Familiar with general quality management system concepts, including good documentation practice (GDP), corrective and preventive action (CAPA), and document change control practices.
Ability to define problems, collect and analyze data, establish facts, and draw conclusions and recommendations Ability to effectively collaborate and connect with internal and external partners at all levels of the organization including influencing and negotiating resulting in positive business and quality outcomes.
Ability to function in a team environment and deliver on team objectives.
Strong attention to detail.
Preferred.
Developed presentation skills.
Statistical software experience (e.
., Minitab).
Knowledgeable with Engineering Drawing Geometric Dimensioning and Tolerancing (GD&T) Familiarity with Medical Device regulation (ISO & CFR).
Other.
This position may require up to 10% of domestic and/or international travel.
The anticipated base salary for this role is $ to $.
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.
Vacation – up to 120 hours per calendar year 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 Holiday pay, including Floating Holidays – up to 13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below.
For additional general information on Company benefits, please go to.
https://www.
areers.
nj.
om/employee-benefits This job posting is anticipated to close on March .
The Company may however extend this time-period, in which case the posting will remain available on https://www.
areers.
nj.
om to accept additional applications.
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.