Senior Manager, Quality Systems 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, Diagnostics, HealthcareIndustries

Requirements

Bachelor’s degree in a scientific or engineering discipline with 9+ years of industry experience OR Master’s degree with 7+ years of industry experience
Minimum 2 years of leadership experience in regulated medical device, diagnostics, or life sciences environments
Proficiency with FDA Quality System Regulation (QSR), ISO 13485, and EU IVDR compliance frameworks
Demonstrated experience implementing and maintaining domestic and international quality management systems
Direct involvement with regulatory audits, inspections, and certification processes in FDA- and ISO-regulated industries
Hands-on experience with electronic quality management systems (eQMS) or document control platforms used in regulated environments
Ability to travel up to 10% for audits, inspections, or operational support

Responsibilities

Manage the Indian Development Center (IDC) Internal Audit program to schedule, execute, and document audits in compliance with Cepheid Policy and procedures, ensuring timely closure of findings with corrective actions
Manage external regulatory audits by organizing pre-audit logistics, hosting audits, and directing post-audit corrective action implementation
Implement and maintain global document control processes aligned with FDA Quality System Regulation (QSR), ISO 13485, and other applicable regulatory standards
Administer and maintain the Quality System Training application, Compliance Wire, ensuring accurate configuration, user access, and training completion tracking
Monitor and ensure compliance with FDA regulations, European Union In Vitro Diagnostic Regulation (IVDR), and other global regulatory requirements applicable to medical devices and diagnostics
Maintain audit records, document control logs, and training system data to provide measurable compliance evidence during inspections and regulatory reviews
Coordinate cross-functional regulatory readiness activities to ensure systems, documentation, and training platforms meet audit and inspection requirements

Skills

Key technologies and capabilities for this role

Quality Management SystemInternal AuditRegulatory ComplianceMedical Device RegulationsIVD StandardsCorrective ActionsExternal AuditsDanaher Business System

Questions & Answers

Common questions about this position

What is the location for this Senior Manager, Quality Systems role?

The position is located in Bengaluru, India.

What are the essential requirements for this position?

A Bachelor’s degree in a scientific or engineering discipline is required.

What does the Quality department do at Cepheid?

The Quality department collaborates with cross-functional business partners to ensure that customer needs and safety are met, government regulations and quality requirements are effectively monitored, measured, maintained and continuously improved.

What is the salary or compensation for this role?

This information is not specified in the job description.

What experience makes a strong candidate for this role?

Strong candidates will have expertise in managing internal audits, external regulatory audits, document control processes aligned with FDA QSR and ISO 13485, and compliance with global regulations like IVDR.

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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