QA Specialist at Danaher Corporation

Bengaluru, Karnataka, India

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Diagnostics, Biotechnology, Life Sciences, ManufacturingIndustries

Requirements

Minimum of 10 years’ experience in software quality in either medical devices or pharma industry or with background in a highly regulated environment
Bachelor’s in life sciences, engineering or quality management or equivalent
Excellent organizational and communication skills
Fluent in English language
Solid working knowledge of EU, FDA and related regulations including QSR’s (FDA 21 CFR 820), ISO 13485 or ISO 9001, IVD’s, IEC62304

Responsibilities

Provide Quality and Compliance expertise for system compliance, authoring, and reviewing end-to-end Design deliverables
Prepare documentation adhering to product development, Software Development Life Cycle processes, and regulatory requirements
Collaborate with teams and provide guidance to project teams on implementing and adhering to quality standards
Maintain and develop IDC quality systems and infrastructure, and monitor QMS performance and drive its fulfillment
Ensure compliance with organizational policies and regulatory requirements, including FDA, ISO 13485, and ISO 14971, with knowledge of IVDR
Send daily status reports to management, highlighting any risks
Support audits by liaising with management and qualify software for validation labs in conjunction with FSCs
Define programs for software design quality improvement
Execute and participate in audits (supplier audits, external audits etc.)
Liaise with Tech-ops and R&D departments on validation requirements for new and current products and processes as well as with the regional and global Q&RA organization to support the growth of and ensure alignment with BEC global policies and procedures

Skills

Quality Assurance

Compliance

Design Control

SDLC

Regulatory Requirements

Quality Systems

Documentation

Product Development

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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