Senior Quality Engineer, Lifecycle Management - Johnson and Johnson
Irvine, CA 92602
About the Job
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 world's 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 product's 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.
- Ensure compliance to Medical Device regulations and standards, including Design Control Regulatory requirements, in worldwide markets for product design and supplier changes.
- Lead and educate other teams within the organization on medical device regulations.
- Collaborate with the lifecycle management team to guide the application of design change controls and risk management, while assessing the effect of changes on design input, design outputs, failure modes, test methods, and design verification and validation activities.
- Support internal and external regulatory compliance audits and drive continuous improvement in quality systems execution across the company.
- Monitor the risk management process to ensure devices continue to meet intended safety and performance standards.
- Evaluate and update inspection methodology, acceptance criteria, and transfer functions for products and components associated with design changes post-product launch.
- Participate in component and service supplier evaluation to maintain high quality standards.
- Provides statistical support and analytical problem solving.
- A Bachelor's degree or its equivalent from a university is required in an Engineering or a Scientific field.
Required:
- A minimum of four (4) years of relevant work experience.
- Proven experience with FDA regulations for medical devices.
- Strong understanding of ISO 13485: 2016.
- Previous experience in the medical or healthcare field.
- Excellent problem-solving, root cause investigation, and decision-making skills.
- Proficient in written, verbal communication, and presentation skills.
- Previous experience in Quality Engineering.
- Experience collaborating effectively with cross-functional teams.
- Working knowledge of applicable requirements related to the MDSAP jurisdictions.
- This position will be located in Irvine, CA, and may require up to 25% domestic or international travel.
- 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)).
- 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
This job posting is anticipated to close on October 15, 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 .