Job Description

Wondering what's within Beckman Coulter Diagnostics? Take a closer look.
At first glance, you'll see that for more than 80 years we've 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. We're building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you'll 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, we're working at the pace of change to improve patient lives with diagnostic tools that address the world's biggest health challenges.
The QA Specialist for Beckman Coulter Diagnostics is responsible to ensure BDC site compliance and support the Design changes for software and hardware instruments.
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 entities
This position is part of the Quality & Regulatory Affairs located in Bangalore and will be fully onsite 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 and report to the Senior 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.
• Ensure compliance to organizational policies, procedures and regulatory requirements such as FDA, ISO 13485, ISO 14971 and Liase with Management to support audits.
• Drive strategic quality initiatives aimed at enhancing product quality, compliance, and customer satisfaction. Lead efforts to streamline processes, reduce defects, and improve overall product reliability.

If you thrive in a supporting role and want to work to build a world-class Quality Assurance organization--read on.

• Lead product or quality projects as Design Quality Engineer as Core Team Member.
• Oversee the QMS for the Bangalore Development Centre (BDC) for Diagnostics, ensuring compliance and effectiveness.
• Collaborate with cross-functional teams to ensure quality requirements are integrated into product development processes. Provide guidance and support to team members on quality and regulatory matters.

The essential requirements of the job include:

• Degree in life sciences, engineering, quality management, or equivalent education obtained through professional experience.
• Over 7+ years of experience working in regulated environments, medical device industries demonstrating a strong understanding of industry standards.
• Extensive software & hardware development process experience or practical experience with product software/hardware verification and/or validation having certified in ISO13485, ISO14971
• Demonstrates a high level of autonomy and critical thinking, with a strong orientation towards teamwork and collaboration.

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

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

Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's 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.
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.