Senior Manager QA at Danaher Corporation

Bengaluru, Karnataka, India

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, Healthcare, Biotechnology, Diagnostics, Life SciencesIndustries

Requirements

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

Responsibilities

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

Skills

Key technologies and capabilities for this role

Design ControlSupplier QualityQuality AssuranceMedical DevicesRegulatory ComplianceR&D PartnershipTeam LeadershipMentoringProduct DevelopmentQuality Management

Questions & Answers

Common questions about this position

Is this a remote position or does it require on-site work?

This is an on-site leadership role located at the Bangalore Development Center (BDC) in Bangalore.

What are the key responsibilities of the Senior QA Manager?

The role involves leading and managing QA teams, driving operational excellence, providing technical leadership in design control, and championing risk-based decisions and compliance.

What regulatory standards must the role ensure compliance with?

The position requires ensuring compliance with FDA, ISO 13485, IEC 60601-1, ISO 14971, and other global regulatory requirements.

What is the company culture like at Radiometer?

Radiometer fosters a culture of belonging where unique viewpoints matter, celebrates diverse ideas and continuous improvement, and emphasizes harnessing the Danaher Business System to turn ideas into impact.

What experience makes a strong candidate for this role?

Strong candidates will have expertise in design control, supplier quality, risk management, and regulatory compliance for medical devices, along with leadership experience in guiding QA teams.

Danaher Corporation

Water quality, diagnostics, and identification solutions

About Danaher Corporation

Danaher Corporation operates in key markets such as water quality, product identification, and diagnostics. The company provides precision instruments and advanced purification technologies for analyzing and managing water, ensuring its safety in various environments. In product identification, Danaher specializes in laser marking, coding, and packaging solutions that help maintain product freshness and accurate labeling throughout the supply chain. In the diagnostics sector, Danaher offers tools and software that enhance diagnostic confidence, enabling healthcare providers to deliver effective care. What sets Danaher apart from competitors is its unique Danaher Business System, which focuses on continuous improvement and empowers employees to drive change. The company's goal is to consistently deliver high-performance products and solutions while maintaining leadership in its markets.

Washington, District of ColumbiaHeadquarters

1969Year Founded

IPOCompany Stage

Industrial & Manufacturing, Healthcare, Consumer GoodsIndustries

10,001+Employees

Risks

Increased competition from Roche and Abbott in AI-driven diagnostics.

Potential regulatory challenges in the EU for water quality sector.

Supply chain vulnerabilities affecting precision instruments sourcing.

Differentiation

Danaher's Danaher Business System drives continuous improvement and superior financial performance.

The acquisition of Cytiva enhances Danaher's capabilities in the biopharmaceutical sector.

Danaher's advanced purification technologies meet increasing demands for sustainable water management.

Upsides

Danaher's investment in AI-driven healthcare solutions boosts its diagnostics capabilities.

Cytiva acquisition expands Danaher's market share in the biopharmaceutical sector.

Point-of-care testing demand drives growth for Danaher's diagnostic tools and software.

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