Senior Manager QA (Medtech)

Job Summary

The Senior QA Manager for Radiometer is responsible for ensuring safe, reliable, and compliant products during new product development and maintenance of existing product platforms, by partnering with R&D. Drive global quality excellence by leading design control and supplier quality initiatives that ensure safe, compliant, and innovative medical devices.

This position is part of the QA Design Control team, located at the Bangalore Development Center (BDC), Bangalore. It is an on-site leadership role responsible for guiding and mentoring team members while driving quality initiatives. As a key leader within the QA Design Control team, you will support design control and supplier quality activities, working collaboratively with QA colleagues across the globe on products related to Immunoassays, Blood Gas, Transcutaneous monitoring and IT System solutions.

In this role, you will have the opportunity to:

• Lead and Manage Teams: Oversee QA professionals and supervisors, ensuring accountability for results, effective team performance, and alignment with departmental goals.
• Drive Operational Excellence: Adapt plans and priorities to address resource constraints and operational challenges while maintaining compliance and supporting business objectives.
• Provide Technical Leadership in Design Control: Guide QA activities in design and development projects, ensuring compliance with FDA, ISO 13485, IEC 60601-1, and other global regulatory requirements.
• Champion Risk-Based Decisions and Compliance: Lead risk management processes (ISO 14971), usability engineering, requirement traceability, and audit readiness for internal and external audits.
• Collaborate Across Functions and Globally: Work closely with R&D, external partners, Supplier Quality, Operations, and Regulatory Affairs to assure quality throughout development, design transfer, and post-launch activities.
• Lead Supplier Quality Management: Drive supplier qualification, audits, compliance, and development initiatives, resolving non-conformances and ensuring continuous improvement across the supply chain.
• Represent QA Leadership and Strategic Influence: Act as a QA representative in leadership forums, influencing long-term planning, harmonizing global quality processes, and driving continuous improvement initiatives using DBS tools.

The essential requirements of the job include:

• Education: M.Tech/B.Tech/BE in Engineering (or equivalent university degree relevant to QA), with strong understanding of product design processes for multi-disciplinary products.
• Experience: 14-18 years in Quality Assurance within Healthcare/Medical Devices, including at least 3 years of people leadership experience.
• Regulatory Expertise: Deep knowledge of QA concepts, design control, supplier quality, and global regulatory standards (FDA 21 CFR 820, ISO 13485, ISO 14971, MDR, IVDR).
• Technical Knowledge: Familiarity with immunoassay principles (ELISA, chemiluminescence, lateral flow), product lifecycle for immunoassay devices (hardware/software), and system engineering concepts.
• Analytical & Process Skills: Experience with analytical performance verification, lab instrumentation, data analysis tools, and process development using lean principles.

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.