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Johnson & Johnson Medical Devices Companies is recruiting for a Quality Engineering Manager located in Palm Beach Gardens, FL The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services. Overall Responsibilities The Quality Engineering Manager will be accountable for the Design Quality Group for the Anspach Power Tools business. This includes the execution and delivery of quality strategies for sustaining engineering and New Product Development (NPD) activities that are aligned with business strategies. This individual should be willing to make a significant contribution to a multi-disciplined team, be self-motivated to act, and have excellent written and verbal communication skills. Position Duties & Responsibilities: Partner with R&D, Operations, Regulatory, and Marketing to assure all sustaining engineering and NPD quality deliverables are met in accordance with all regulatory standards (e.g. FDA 21 CFR Part 820, ISO13485, EU MD Directive/Regulations, Japan JPAL, Canada CMDCAS, Brazil ANVISA, Australia TGA and all other applicable regulatory standards considering the countries/regions products are marketed.) within cost, quality, and schedule targets. Manage the Design Quality engineering resources and allocate across sustaining engineering and NPD projects as needed to support business objectives. Monitor quality metrics across the business unit to identify systemic product and process issues, assuring appropriate investigation, correction, and corrective and preventive action when needed. Partner with R&D, Operations, Regulatory, and Marketing to assure there is appropriate execution of risk management and design controls and process validation for new and existing products. Know and follow all laws, standards, and policies that apply to one's job, and maintain the highest levels of professionalism, ethics, and compliance at all times. Diligently participate in compliance program-related activities as denoted by leadership or our Chief Compliance Officer. Promote and nurture the highest standards of professionalism, ethics, and compliance, and actively support our compliance program-related initiatives and activities. Consistently enforce employee compliance, including attendance at training programs, and promptly report any non-compliance to the Chief Compliance Officer. 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, both within Quality and cross functionally with departments such as Product Development, Regulatory, Manufacturing, and Marketing. Qualifications Education & Required Skills/Experiences A minimum of a bachelor’s degree is required. A degree in engineering and/or in a technical science is a plus. A master’s degree is a plus. A minimum of 10 years related working experience in a GMP and/or ISO regulated industry with a minimum of 5 years people management or project management experience NPD Quality Experience specific to QSR Design Control requirements Candidate should have a proven track record implementing Quality System improvements to meet compliance and overall business goals. Proficiency with the Microsoft Office Suite Ability to effectively present complex information in a clear and concise manner Previous experience managing multiple projects Ability to clearly communicate to a variety of audiences, both big picture ideas as well as technical details Preferred Skills/Experiences 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 Previous experience in a medical device or a healthcare discipline Strong working knowledge of QSR (21 CFR 820), ISO (13485, 14971), and all country specific regulatory requirements is strongly Blueprint literacy including GD&T Knowledge of process and design excellence tools is strongly preferred. Certification is a plus. Other: This position will be based in Palm Beach Gardens, FL and will require up to 10% travel, potentially including international travel. At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. 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 United States-Florida-Palm Beach Gardens-4500 Riverside Drive Organization Medical Device Business Services, Inc (6029) Job Function Engineering Requisition ID 2206021998W
Child care benefits
Short term disability