QA Specialist I

Job Description

At Cepheid, we are passionate about improving healthcare through faster, more accurate diagnostic tests. With our GeneXpert System, we ve taken the most sophisticated molecular technology and packaged it into an automated, easy-to-use format that has quickly become the platform of choice worldwide. From the largest laboratories to small physician offices, our game-changing solution delivers critical answers when clinicians and patients need them most. Through strong molecular biology capabilities and ongoing product innovation, we are focused on developing tests for healthcare-associated infections, sexual health, critical infectious disease, virology, and oncology applications. Come join our vision for a better way and help make life better for us all! For more details, visit us at www.cepheid.com or follow us on Twitter (@CepheidNews).This position is for Cepheid team located at Danaher India Development Center (IDC), BangaloreIDC is a research and development center with the vision of accelerating product roadmaps across various Danaher business segments. Started in 2014, the center now hosts 500+ associates, for multiple Danaher operating companies focusing on Diagnostics, Life Science, and Environmental and Applied Science segments. The operating companies includes Beckman Coulter, Radiometer, Leica Biosystems, Danaher Digital, Hach, Leica Microsystems, HemoCue, Videojet and Cepheid. The IDC workforce comprises of various product engineering teams, working on development of software and hardware components of cutting-edge products for, Immunoassay, Chemistry, Hematology, Molecular diagnostics, Oncology, Neurosurgery and Water Quality. IDC has evolved as center of excellence for Cloud and data analytics, with significant contributions to the key informatics solutions. The teams consist of highly skilled software & hardware engineers and development managers. The teams are supported by local Product managers, Quality & Regulatory and Intellectual property specialists.The inhouse teams works in close coordination with other global R&D centers at US, France, Germany, Japan, Australia, Denmark and Sweden. Located at the center of Bangalore IT HUB, IDC is housed at state of art facility, measuring 120 K Sqft.Cepheid is looking for a Quality Engineer responsible for performing software verification testing of software products as per medical device standards and regulations. Provides guidance to the core team to organize project structure and documentation to meet design control requirements. Support design changes to established products.Essential Job Responsibilities: Develop and execute Verification plans and protocols and Summary Reports. Ensure conformity of the design process with applicable regulation Experience of working in an Agile environment, testing requirements Review and Approve verification documentation related to the products he/she s in charge Create and compile design control deliverables for regulatory submissions Traceability Analysis Report and V&V Summary report Collaborate with distributed, cross-functional teams to ensure products meet quality, performance, scalability, reliability and scheduled goals Works closely with the software development team, the software quality team, the functional manager and the project manager. Conduct risk assessment meetings with key stakeholders Liase with the Lab Manager to ensure validation of the instruments is maintained at all times. Ensure compliance to organizational policies, procedures and regulatory requirements such as FDA, ISO 13485What We Are Looking For: Degree in sciences, life sciences, engineering or quality management or equivalent education gained through work experiences 8 years+ experience within the regulated environment of in vitro diagnostics or medical devices Fluent in English - written and verbal Experience in design verification and/or validation and generation of associated protocols gained either from in house testing simulating end use or actual end use in a clinical environment Software development process experience or practical experience with product software verification and/or validation Analytical skills Self-starter with a sense of urgency to resolve issues and complete projects. Passionate about the team, customers, quality, sharing knowledge and collaborating across teams. Is self-aware. Is a team player Has a strong work ethic Practical experience of workflows in laboratory environments is a plus Knowledge of IEC62304, ISO14971, 21CFR820, ISO13485, ISO17025 High level of autonomy and critical thinking is required. Teamwork oriented. Computer skills (MS Office products)Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years. At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. Were innovative, fast-paced, results-oriented, and we win. We need skilled people to keep winning. Here youll learn how DBS is used to shape strategy, focus execution, align our people, and bring value for customers and shareholders. Come join our winning team. Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive. Equal Opportunity EmployerDanaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The EEO is the Law poster is available here .,

Keyskills :
test case designtest scenariosenvironmentiso 13485in vitrocenter of excellencetest executionin vitro diagnosticsdanaher business systemtest casesstatements of work sowresearch developmentglobal rd