Senior 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

Life Sciences, Diagnostics, Biotechnology, HealthcareIndustries

Requirements

Expertise in design control elements including risk management (ISO 14971), usability engineering, requirement traceability, and medical device testing (IEC 60601-1)
Knowledge of FDA, ISO, and other global regulatory requirements for medical devices/IVD
Up-to-date knowledge of standards, regulatory requirements, and regulations applicable for Medical Devices/IVD
Ability to collaborate with multifunctional teams including R&D, external R&D partners, Supplier Quality, Operations, Procurement, and RA
Experience with supplier quality management, including qualifying, monitoring, auditing suppliers, and handling non-conformances/CAPAs
Familiarity with ISO 13485, FDA 21 CFR Part 820
Ability to mentor junior QA team members and contribute to quality training programs
Proficiency in Danaher Business System (DBS) tools and demonstrating Danaher values
On-site role at BDC (Bangalore Development Center), Bangalore

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, usability engineering, requirement traceability, and medical device testing
Review and approve design documentation, verification and validation protocols, and reports
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 development, design transfer, and post-launch
Mentor junior QA team members and contribute to quality training programs
Keep up-to-date on standards and regulations, and update relevant parts of the QA system
Ensure projects and teams at BDC are audit-ready and provide support during internal and external audits
Provide support in driving BDC-specific Quality initiatives
Collaborate with Supplier Quality and Procurement to qualify, monitor, and audit suppliers
Review and approve supplier quality documentation change notifications
Lead investigations and resolution of supplier-related non-conformances and CAPAs
Support supplier development initiatives and drive continuous improvement in supplier performance
Participate in supplier audits at Outsourced Design Partners
Ensure supplier compliance with applicable standards and regulations (ISO 13485, FDA 21 CFR Part 820)

Skills

Key technologies and capabilities for this role

QADesign ControlSupplier QualityImmunoassaysBlood GasTranscutaneous MonitoringIT SystemsR&DRegulatory Compliance

Questions & Answers

Common questions about this position

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

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

What are the key responsibilities of the Senior 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), and compliance with FDA and ISO regulations is required, along with experience in supporting design transfer and post-market activities.

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 while prioritizing life and improving global healthcare.

What makes a strong candidate for this Senior QA Specialist role?

A strong candidate thrives in a multifunctional role, has experience leading QA in design control and outsourced development, can collaborate globally with R&D and other teams, and is able to mentor junior QA members while ensuring regulatory compliance.

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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