QA Specialist I at Danaher Corporation

Bengaluru, Karnataka, India

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Life Sciences, Diagnostics, Biotechnology, HealthcareIndustries

Requirements

M.Tech / B.Tech / BE degree in engineering, with strength in product design processes of multi-disciplinary products (or other university-level education relevant for QA work with good technical understanding and ability to learn technical aspects quickly)
8 to 10 years of proven experience as a quality assurance professional in a Healthcare domain

Responsibilities

Lead QA activities in design and development projects with a focus on Outsourced Design, ensuring compliance with FDA, ISO, and other global regulatory requirements
Provide expert guidance on design control elements including risk management (ISO 14971), usability engineering, requirement traceability, medical device testing (IEC 60601-1)
Review and approve design documentation, verification and validation protocols, and reports
Participate in supplier audits at Outsourced Design Partners
Facilitate risk assessments and contribute to risk management files
Support design transfer and post-market activities ensuring continuous compliance and improvement
Collaborate closely with R&D, external R&D partners, Supplier Quality, Operations, and RA to assure high quality throughout the development process including design transfer and post-launch activities
Mentor junior QA team members and contribute to quality training programs
Keep up-to-date knowledge of standards, regulatory requirements, and regulations applicable for Medical Devices/IVD and ensure updating relevant parts of the QA system
Ensure that projects and teams at BDC are audit-ready and provide support during internal and external audits of BDC
Provide support in driving BDC-specific Quality initiatives
Demonstrate Danaher values and adopt DBS tools

Skills

Key technologies and capabilities for this role

QADesign ControlQuality AssuranceR&DImmunoassaysBlood GasTranscutaneous MonitoringIT SystemsRegulatory ComplianceProduct Development

Questions & Answers

Common questions about this position

Is this QA Specialist role remote or on-site?

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

What are the key responsibilities of the QA Specialist?

The role involves leading QA activities in design and development projects, ensuring compliance with FDA, ISO, and other regulations, providing guidance on design control elements like risk management and usability engineering, reviewing design documentation, and collaborating with R&D, suppliers, and other teams.

What skills and experience are required for this position?

Expertise in design control, risk management (ISO 14971), usability engineering, requirement traceability, medical device testing (IEC 60601-1), FDA and ISO compliance, supplier audits, and collaboration with R&D and global teams is required.

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 innovate and turn ideas into impact.

What makes a strong candidate for this QA Specialist role?

Strong candidates thrive in multifunctional roles, have experience leading QA in design control for outsourced projects, expertise in regulatory compliance and risk management, and the ability to collaborate globally while mentoring juniors.

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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