Quality Engineer, FUME Lead (QS&C)
The Quality Engineer, FUME Lead (QS&C) at Kyowa Kirin North America is a vital role within the Quality Systems & Compliance team, dedicated to advancing the quality assurance processes at a prominent pharmaceutical company. Kyowa Kirin is recognized for its commitment to innovative therapies and a patient-focused approach within the biopharmaceutical industry. The FUME Lead will contribute within a highly collaborative environment that values both technical expertise and strategic thinking.
The primary responsibilities include leading the execution and continuous improvement of the Failure, Use, Misuse, and Error (FUME) process. This individual will ensure robust analysis and documentation of product quality events, investigate deviations, and work with cross-functional teams to address systemic issues. The role requires effective communication across departments and participation in audits, inspections, and risk management activities.
Candidates should have a bachelor's degree in engineering, life sciences, or a related discipline. Several years of experience in quality assurance, preferably within a regulated biopharmaceutical or medical device environment, is expected. Familiarity with global regulatory standards, strong analytical skills, and hands-on knowledge of failure mode analysis and risk assessment practices are essential. Candidates should also demonstrate excellent project management and interpersonal skills.
Kyowa Kirin offers a comprehensive benefits package that typically includes health insurance, retirement plans, paid time off, and wellness programs. Employees have access to professional development opportunities and the support of an inclusive corporate culture focused on growth and work-life balance.
The company is known for fostering individual growth and innovation, encouraging continuous learning and advancement within the organization. This position offers a chance to make a meaningful impact in a company dedicated to improving patient lives through cutting-edge science and high-quality standards.