Technical Quality Assurance Associate & CSV Expert at Danaher Corporation

Munich, Bavaria, Germany

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Not SpecifiedCompensation

Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Life Sciences, Diagnostics, PharmaceuticalsIndustries

Requirements

Minimum 3 - maximum 10 years of experience in Software QA, ideally in life sciences software industries
Strong understanding of GxP, FDA 21 CFR Part 11, ISO 9001, and GAMP5
Experience with audit preparation and compliance documentation
Compliance-Focused Technical Proficiency: Hands-on experience (inferred from profile)

Responsibilities

Lead and manage all QA activities within the Genedata Expressionist Business Unit, ensuring alignment with regulatory and business objectives
Continually improve and maintain effective QMS processes to enhance product quality and operational efficiency
Define, review, and maintain software requirements and documentation in compliance with GxP, FDA 21 CFR Part 11, ISO, and other relevant regulations and standards
Ensure full traceability from requirements through implementation and testing to support, validation and audit readiness
Collaborate with cross-functional teams (Product Management, Development, DevOps, Support) to embed quality throughout the software lifecycle
Provide software validation services to customers in regulated environments, including documentation, test protocols, and audit support
Act as a subject matter expert on software validation and compliance in both internal and customer-facing contexts
Support pre- and post-sales teams in understanding user requirements and ensuring successful software solution roll-out in regulated environments
Train internal teams on compliance topics such as GxP, 21 CFR Part 11, GAMP5, and GDPR
Facilitate and support internal, customer, and regulatory audits as needed

Skills

Software QA

Quality Management System

QMS

Software Validation

Regulatory Compliance

CSV

Genedata Expressionist

Life Sciences

Biopharma R&D

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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