Johnson & Johnson is recruiting for a Staff Quality Engineer ! This position will be located in Memphis, TN .
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 Are you ready to make an impact?
If you want to leave your personal mark and be valued for who you are, Johnson & Johnson offers an unusual experience to professionals looking for an opportunity to work with hardworking people who share your real passion for caring in an environment that empowers you to drive your own career and that you feel you can bring your whole self to work.
We are looking for someone to support the New Product Development Quality group to implement engineering and quality systems, and regulatory compliance strategies and objectives. As the Staff Quality Engineer you will get hands-on experience as part of a team to implement state-of-the-art quality engineering focus and improvements in design and development of products, and in transfer and steady state phases of manufacturing operations. Key responsibilities: Product development team member focused on product development and life cycle management activities related to the CrossRoads business. Lead design and development planning activities for new and sustaining projects. Participate in all aspects of the creation and execution of functional/design requirements for new and sustaining projects. Conduct formal technical design reviews throughout the phases of the product development process. Support and approve design verification/validation activities including mechanical testing, tolerance analyses, design rationales, and surgeon based anatomical labs. Apply statistical methods and design excellence tools to design verification and validation activities. Support risk management activities including planning, design & clinical risk management, production risk management, and overall risk summary reporting. Support transfer to manufacturing activities both in product development and base businesses. Enhance the design control and risk management processes to better reflect state of the art practices and drive continuous improvement. Provide leadership in all areas of the Quality System, including, but not limited to corrective & preventive actions, product complaints, post market surveillance, nonconforming materials, risk management, and audit support functions. Provide leadership in the understanding of medical device regulations to other disciplines. Communicate effectively at all levels within Quality, as well as cross functionally with departments such as Product Development, Regulatory, Manufacturing, and Marketing. Work closely with suppliers on the qualification of new/changed parts and processes supporting product development. This person will conduct assessments of new suppliers as part of the project teams. Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics , and compliance at all times. Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer. Additional duties as assigned. Education :
A minimum of a Bachelor's or equivalent University degree is required with a focus in Engineering and/or in a Technical Science preferred. A Master's degree is a plus. Required: A minimum of 6 years of related working experience in a GMP and/or ISO regulated industry. Strong design/quality engineering skills with a proven track - record in all aspects of the design control process, including functional/design requirements, design verification/validation, and product risk management. Strong working knowledge of QSR (21 CFR 820) and ISO (13485, 14971) quality requirements . Candidate should possess excellent problem solving, decision-making, and root cause analysis skills in addition to people skills that foster conflict resolution as it relates to technical situations. Candidate should have a proven track-record implementing Quality System improvements to meet compliance and overall business goals. Proficiency with the Microsoft Office Suite Preferred: Blueprint literacy including GD&T Knowledge of process and design excellence tools is strongly preferred; Certification is a plus Working knowledge related to orthopedic implantable, product software, and software validation Strong working knowledge of Analytical Tools and Advanced Statistical Analysis Other: This position may require up to 10% domestic & international travel. Six Sigma/Process or Design Excellence training, and/or certification. Ready to be part of something great? Don't forget to apply. We want YOU!
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.
