As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory s role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, and are used in hospitals, reference and research laboratories, and physician offices around the world. Every hour around the world, more than one million tests are run on Beckman Coulter Diagnostics systems, impacting 1.2 billion patients and more than three million clinicians per year. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence.

The Senior Manufacturing Quality Engineer for Beckman Coulter Diagnostics is responsible for:

Provide Quality and Compliance expertise for system compliance, authoring, and reviewing end to end Design deliverables.
Prepare documentation adhering to product development, Software Development Life Cycle processes, and regulatory requirements.
Collaborate with teams guidance to project teams on implementing and adhering to quality standards.
Maintain and develop IDC quality systems and infrastructure, and to monitor QMS performance and drive its fulfillment.
Ensure compliance with organizational policies and regulatory requirements, including FDA, ISO 13485, and ISO 14971, with knowledge of IVDR.
Send daily status reports to management, highlighting any risks.
Support audits by liaising with management and qualify software for validation labs in conjunction with FSCs.

This position is part of the International Quality Operations located at Bengaluru, India and will be on-site. At Beckman Coulter, our mission is to Relentlessly Reimagine Healthcare, One Diagnosis at a Time.

You will be a part of the Quality, Regulatory and Clinical Affairs and report to the Senior Manager Quality and Regulatory Affairs. If you thrive in a multifunctional role and want to work to build a world-class Quality organization read on.

In this role, you will have the opportunity to:

Define programs for software design quality improvement
Execute and participate in audits(supplier audits, external audits etc)
Liaise with Tech-ops and R&D departments on validation requirements for new and current products and processes as well as with the regional and global Q&RA organization to support the growth of and ensure alignment with BEC global policies and procedures

The essential requirements of the job include:

Minimum of 10 years experience in software quality in either medical devices or pharma industry or with background in a highly regulated environment with Bachelors in life sciences, engineering or quality management or equivalent
Excellent organizational and communication skills and fluent in English language is required
Solid working knowledge of EU, FDA and related regulations including QSR s, (FDA 21 CFR 820), ISO 13485 or ISO 9001, IVD s, IEC62304

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

Experienced in quality management methods (8D, Six Sigma, Statistical Tools, FMEA)
Experienced in working within multi-functional, multi-regional teams

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QA Specialist