Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Beckman Coulter Diagnostics, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.
You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.
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.
Learn about the Danaher Business System which makes everything possible.
The Specialist, Commercial Quality Assurance is responsible for Post Market Surveillance (Field Action Management, Adverse Event & Complaint Management), Supplier Management & Audit Management (Internal audits, Sales Channel Partner & Supplier Audits) .
This position reports to the Manager, Commercial Quality Assurance (SWA) and is part of the Commercial Quality Assurance Center of Excellence (COE) located in New Delhi, India and will be an on-site role.
In this role, you will have the opportunity to:
- Post Market Surveillance Activities (Field Action/Recall/Adverse Events Management – Assessment, Internal communication, Customer data base Management, End Customer Communication within defined timelines as per Beckman procedures
- Supplier Management: Category Assessment, Supplier documents review, Onboarding & updation into Supplier Sharepoint, Annual Performance review.
- Audit Management: Internal Audits, Supplier & Sales Channel Partner Audits (Preparation of Audit Plan, Conduct of audit, Audit Report etc.)
- Non-Conformance (NC) Management: Classification of High, Medium & Low Findings & Closure into Smartsolve
- CAPA Management: Including Fasttrack CAPA, within defined timelines
The essential requirements of the job include:
• Requires Degree in a Science / Pharmacy or related field.
• At least 8- 10 years of relevant experience within Quality Assurance in medical devices or IVD industry and in-depth knowledge of QMS requirements.
• Knowledge and experience for handling Post Market Surveillance activities & Supplier and Audit Management (Non conformances & CAPA)
• Experience in working in a matrix organization, international environment and experience in handling projects independently.
• IT literate with MS Office.
Travel, Motor Vehicle Record & Physical/Environment Requirements: if applicable for role
- Ability to travel – list specifics % travel, overnight, within territory or locations
- Must have a valid driver’s license with an acceptable driving record
- Ability to lift, move or carry equipment up to ##lb, any other physical requirements
It would be a plus if you also possess previous experience in:
Also, candidate having knowledge & practical experience (handling Import license, retention & post approval change submissions) of medical device regulation 2017 would be preferred.
Beckman Coulter Diagnostics, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.
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 www.danaher.com.
