Staff Quality Engineer, Life Cycle Management - 2406216936W

Description

Johnson & Johnson is seeking a Staff Engineer with outstanding problem-solving and analytical skills to join our Quality Engineering Lifecycle Management team 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.jnj.com/ .

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the worlds most pressing healthcare challenges.

We know that the success of our business and our ability to deliver meaningful solutions depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

In this role you will represent the Quality Engineering function for marketed product and the state of quality and compliance throughout the products life cycle. You will ensure sustaining engineering projects are conducted in compliance with internal, customer, and regulatory requirements!

This is a unique opportunity to contribute to a world-class organization that is committed to improving health outcomes and transforming the future of healthcare. If you are ready to make a significant impact in the field of healthcare and join a global leader in innovation, we encourage you to apply now!

Key Responsibilities:

• Design Quality team member focused on lifecycle management activities associated with Neurovascular products.

• Ensures compliance to Medical Device regulations and standards, i.e. Design Control Regulatory requirements in world-wide markets for product design and supplier changes.

• Guide lifecycle management teams on efficient and effective application of design change controls and risk management. Works to identify effect of changes on design input, design outputs, failure modes, test methods and design verification and validation activities.

• Design Quality Representative for EU MDR technical documentation changes and collaborates with the Regulatory Affairs team on the preparation of deliverables for regulatory filings.

• Supports internal and external regulatory compliance audits.

• Leads thorough investigation of quality issues and effective corrective and/or preventive action plans.

• Monitors risk management process via the Post Market Surveillance process to ensure devices continue to meet intended safety and performance and drive continuous improvement.

• Communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Regulatory, Manufacturing, and Marketing.

Qualifications

Education:

• A minimum of a Bachelor's degree or University equivalent is required, Engineering or Scientific discipline preferred.

Experience and Skills:

Required:

• A minimum of six (6) years of relevant work experience is required, eight (8) years preferred.

• Proven experience with FDA regulations for medical devices.

• Strong understanding of ISO 13485: 2016.

• Previous experience in the medical or healthcare field.

• Familiarity with inspection methods and sampling techniques as well as a proficiency in test method validation.

• Working knowledge of applicable requirements related to the MDSAP jurisdictions and EU MDR.

• Excellent problem-solving, root cause investigation, and decision-making skills.

• Proficient in written, verbal communication, and presentation skills to participate in Management Reviews, host meetings with other internal functions as well as contact with external functions such as government agencies (i.e., FDA), Competent Authorities, third party suppliers, etc.

Preferred:

• Prior Quality Engineering experience.

• Experience collaborating effectively with cross-functional teams and fostering conflict resolution when needed.

• Proven ability to handle conflicting priorities and meet deliverables and deadlines.

Other:

• This position will be located in Irvine, CA, and may require up to 10% domestic or international travel.

The anticipated base pay range for this position is $90,000 to $144,900.

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 corporations performance over a calendar/performance year. Bonuses are awarded at the Companys 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 Companys consolidated retirement plan (pension) and savings plan (401(k)).

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

For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits

This job posting is anticipated to close on October 31, 2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

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.

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 (https://jnjc.taleo.net/enterprise/www.careers.jnj.com) .

Primary Location NA-US-California-Irvine

Organization Medical Device Business Services, Inc (6029)

Travel Yes, 10 % of the Time

Job Function Quality Engineering

Req ID: 2406216936W