Job Description

Be part of something altogether life-changing! Working at Cytiva in the Life Sciences industry means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies. At Cytiva you will be able to continuously improve yourself and us - working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40 countries, Cytiva is a place where every day is a learning opportunity - so you can grow your career and expand your skills in the long term. Cytiva is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we\'re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives. What you\'ll do Responsible for maintaining and improving the Quality Management System to ensure product/solution quality and customer satisfaction by maintaining and improving related processes. Ownership and Management of PASS Quality Management System and Regulatory Compliance in accordance with the Cytvia Quality Systems and Global Quality requirements. Manages quality oversight on all PASS products for PUNE Responsible for ensuring the PASS Quality Management System adheres to ISO 9001:2015 requirements. Manage and develop internal and external audit schedules. Responsible for auditing internal and external suppliers as well as internal processes. Manage customer audits and follow up actions. Responsible for ensuring root cause analysis (RCA) and corrective actions (CA) are deployed and ingrained throughout the organization. Manages and is responsible for skills advancement and training of the PASS team. Responsible for the development and continuous improvement of quality processes and standard work. Supports procurement in supplier selection and is approval authority for quality aspects. Manage complaint and CAPA systems and processes for PASS PUNE. Monitors, manages and provide organizational KPI performance on a monthly basis to ensure business continuity on a high-quality level. Partners with engineering to correct non-conformances and/or recommend process changes to meet quality objectives/requirements. Has ownership over non-conformance process within QMS. Owns and manages customer complaint and customer feedback processes. Support Project Management through project document development. Support PASS senior Management Team in continuous improvement activities. Provide training and coaching of personnel in all functions to understand and comply with customer quality system requirements. Has ownership of training records and maintenance of training records in accordance with ISO 9001:2015 requirements. Completion of customer responses to questionnaires for applicable groups within ISO scope. Administration of standards and relevant regulations for applicable products and groups within the ISO scope. Who you are Bachelor\'s Degree in engineering, biology, or science related field. Minimum of 3-5 years of related experience with quality. Supplier management experience including selection, auditing, approval, and monitoring. Internal and external QMS audit experience. Experience with QMS documentation, CAPA and audit documentation tools. When you join us, you\'ll also be joining Danaher\'s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you\'ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful tools and the stability of a tested organization. At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve.Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes. If you\'ve ever wondered what\'s within you, there\'s no better time to find out.

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