Job Summary

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).

Reports to: Manager, Commercial Quality Assurance (SWA).

Location: New Delhi, India. In office 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

- QSMR Management:



Organizing management review meetings

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 setting and experience in handling projects independently.

- IT literate with MS Office.

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

- Audits (Internal, Channel Partner management & supplier management) with ISO 9001:2015 lead auditor certification.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Specialist, Commercial Quality Assurance (New Delhi)
🏢 Beckman Coulter
📍 New Delhi