Principal Quality Systems Engineer

Johnson & Johnson's Family of Companies is recruiting a Principal Quality Systems Engineer. The location for this position can be either Redwood City, CA or Santa Clara, CA! Robotics and Digital Solutions, is part of Johnson & Johnson Med Tech. At Johnson & Johnson Robotics and Digital Solutions, we’re changing the trajectory of health for humanity, using robotics to enhance healthcare providers’ abilities and improve patients’ diagnoses, treatments, and recovery times. Johnson & Johnson Robotics was established in 2020 with the integration of Auris Health, Verb Surgical, C-SATS, and Ethicon. It comprises three key med-tech platforms: Flexible Robotics (MONARCH®), Surgical Robotics (OTTAVA™), and Digital Solutions. Join our collaborative, rapidly growing teams in the San Francisco Bay Area (Redwood City and Santa Clara), Cincinnati, and Seattle. You’ll collaborate on breakthrough medical technologies that unite multiple subject areas to build a connected digital ecosystem that advances medical professionals’ skills and improves patient outcomes. This individual will report directly to the Sr. Director of Quality Management Systems and Compliance. This role is a vital in partnering with J&J peers to ensure the implementation of robust digital quality systems to enable the Quality Management System for the Robotics and Digital Solutions team. This individual will support Management Review, take a leadership role in preparing and coordinating external audits and helps forge a QMS that supports the evolving and expanding markets served by our products. This is a role for an inquisitive individual that can leverage their hands-on experience and passion to serve as a compliance mentor and promote a culture of quality. This driven team-player will become intimately familiar with our medical devices and play a key role in the development and implementation of continuous product and process improvements. Job Responsibilities: Collaborates with MedTech Quality Systems peers to implement digital solutions to support the Quality Management System and support tracking and trending to enable the early detection of quality indicators. Partners with cross-functional team members to implement new and enhance quality management processes and procedures that support commercial expansion into global markets. Collects and reports Quality System Metrics and tracks of progress in achieving the organizations Quality Objectives. Works with senior leaders to coordinate the communication and review of quality data in Management Review and monthly forums. Performs other related duties as assigned. Qualifications Required: Bachelor of Science degree in an Engineering or other STEM related field 10 or more years of proven industry experience At least 5 years of proven experience coordinating QMS improvements or expanding the scope of a Quality Management System to meet new regulatory requirements. Four years or more of demonstrated ability in a regulated environment that includes working with ISO 13485 and 14971, GMP guidelines, FDA regulations Experience with digital solutions such as EtQ, Trackwise, Qlik, Agile, SAP, Cornerstone for the management of Quality Systems. Proven understanding and ability in the use of trend analysis, Pareto, and other basic charting techniques Must have previous experience coordinating registrations and external audits with notified bodies and regulatory agencies. Sophisticated analytical and problem-solving skills Confirmed ability to articulate risk and make critical decisions regarding quality system compliance and product quality. Outstanding communication, presentation and interpersonal skills. Ability to work at both the Redwood City and Santa Clara, CA sites. Ability to travel up to 10%, international and domestic Preferred: Prior experience hosting or supporting Management Review. Previous experience in a management role or role that influences key stakeholders across functional areas. Demonstrated knowledge across multiple aspects of quality systems and quality engineering Knowledge of European, Japanese, Canadian, Chinese and Korean medical device regulations is desirable. Can provide compliance mentoring to business partners Flexibility to support changing assignments and priorities in an independent and reliable manner while maintaining a positive and collaborative demeanor Six-Sigma, ASQ CQE, or similar certifications 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-California-Redwood City-150 Shoreline Dr Other Locations United States-California-Santa Clara Organization Auris Health, Inc. (6267) Job Function Engineering Requisition ID 2206046689W