Job Description

Wondering whats within Beckman Coulter Diagnostics? Take a closer look.At first glance, youll see that for more than 80 years weve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. Were building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and youll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, were working at the pace of change to improve patient lives with diagnostic tools that address the worlds biggest health challenges.The QA Specialist for Beckman Coulter Diagnostics is responsible to execute and review of computer system validation/qualification for computer systems as per companys procedures. This includes prepare and/or review verification and validation protocols, test cases and results traceable back to identified risks. The role, in collaboration with design and development engineering and other stakeholders, will ensure that the design intent and applicable compliance requirements are met including security controls.Provide quality assurance services to ensure the integrity of products received and shipped out, services provided to clients, support business and customer needs, and comply with government regulations, industry and OpCo standards. May be responsible for supplier selection & auditing, material qualification, material inspection and test, performance monitoring and supplier development. May manage process and product non-conformances in line with company procedures. May conduct quality assurance tests to ensure product specifications are met. May review, investigate, resolve and report on quality discrepancies. May develop, maintain, monitor, and audit quality management system and protocols including systems automation,processes, and procedures that ensure compliance with regulations and standards. May monitor, investigate, and report on customer complaints. May obtain the necessary quality system certifications and licenses (e.g. ISO, CE) to support market release of new product development. May lead audit and inspection preparation, resolution of audit and inspection findings. May have frequent interaction with other functional areas and operating entitiesThis position is part of the Quality & Regulatory Affairs located in Bangalore and will be hybrid At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.You will be a part of the Quality Assurance team at IDC Bangalore and report to the Manager - Quality & Regulatory Affairs responsible for

• Provide Quality and Compliance expertise to ensure system compliance with requirements.
• Provide and/or review protocols/reports / status / schedules of testing activity and results and authoring documentation as required by product development processes, Software Development Life Cycle processes in compliance with regulatory requirements, such as USFDA, ISO 13485 standards.
• Establish and drive successful fulfillment of Quality Management System by maintaining and continuously developing IDC quality systems to ensure compliance and effectiveness.
• Responsible to send daily status reports and highlight risks as appropriate to the Management.
• Ensure compliance to organizational policies, procedures and regulatory requirements such as FDA, ISO 13485, ISO 14971 and Liase with Management to support audits.

If you thrive in a supporting role and want to work to build a world-class Quality Assurance organization read on.In this role, you will have the opportunity to:

• Lead product or quality projects as Design Quality Engineer as Core Team Member.
• Degree in sciences, life sciences, engineering or quality management or equivalent education gained through work experiences.
• 7 years+ experience within the regulated environment
• Extensive software development process experience or practical experience with product software verification and/or validation having certified in ISO13485, ISO14971
• High level of autonomy and critical thinking is required. Teamwork oriented.

It would be a plus if you also possess previous experience in:

• Certifications (ex: ISO27001 preferred)
• Experience working with cloud services environment under regulations.

At Beckman Coulter Diagnostics we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Beckman Coulter Diagnostics can provide.At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrows science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering whats next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit .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.

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