[Quality] Customer Quality Supervisor (Surgical Vision)
Johnson & JohnsonAt 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 jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Within Customer Quality, Reliability Assurance, this position is responsible for collecting and evaluating product quality information, including complaints and other quality-related information, in the Japanese market in compliance with applicable regulations, company policies (including J&J Standards), and the Quality Management System. The role provides appropriate information and reporting to customers and regulatory authorities as required.
In collaboration with manufacturers and suppliers, this position conducts complaint investigations and communicates investigation results to customers.
Supervise team members' daily activities and provide leadership to ensure effective execution of responsibilities. Lead continuous improvement initiatives to enhance team performance and operational efficiency. Evaluate quality-related information, including product complaints, collected through commercial functions and other departments (including Technical Service), in accordance with internal policies, local regulations, and J&J Standards. Collaborate with manufacturers, suppliers, and relevant stakeholders to conduct complaint investigations and determine root causes. Upon request from commercial functions and other stakeholders, provide support for quality-critical or complex complaint cases. This may include customer interactions, on-site visits to customer facilities, verification of reported events, information gathering, and coordination with relevant internal and external stakeholders. Work closely with manufacturers and cross-functional partners to drive issue resolution. Monitor complaint trends within Japan and, when unusual trends are identified, communicate findings to manufacturers and responsible quality management personnel. Participate in investigations and improvement activities as appropriate. Review and assess investigation results and corrective and preventive actions (CAPA) provided by manufacturers, including third-party manufacturers, and report assessment outcomes to responsible quality management personnel. Support implementation of necessary actions within Japan. Support product recall and field action activities as a member of the Reliability Assurance organization to ensure timely and effective execution.
Bachelor's degree or equivalent qualification required. Degree in Physics, Chemistry, Biology, Engineering, Information Science, Metallurgy, Electrical Engineering, Mechanical Engineering, Pharmaceutical Sciences, Medicine, Dentistry, or a related discipline preferred. Minimum of two years of experience in complaint handling, quality assurance, quality control, or manufacturing operations. Experience in the pharmaceutical and/or medical device industry is preferred. Practical knowledge of applicable regulations and Quality Management System (QMS) requirements, with demonstrated experience applying such requirements in the workplace. Experience leading a team and/or project is preferred. Business-level English communication skills, both written and verbal. Strong general computer skills. Excellent written and verbal communication skills with regulatory authorities, internal stakeholders, and external parties. Strong sense of ownership, with the ability to work proactively and adapt flexibly to achieve objectives. Location: Tokyo Headquarters. Travel Requirements: Occasional domestic travel. International travel as business needs require.
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