Staff Quality Assurance Engineer at Danaher Corporation

Indianapolis, Indiana, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Life Sciences, Diagnostics, BiotechnologyIndustries

Requirements

Degree in engineering or other science or related field; or equivalent experience required
BS+7 or MS+4 years’ experience in product development, manufacturing and/or quality systems (ISO 9001), medical device (ISO 13485), pharmaceutical, related life sciences or other regulated industries

Responsibilities

Representing quality assurance on development teams, quality systems and product improvement projects for Beckman Coulter Life Science
Coaching teams with application of ISO 9001/13485/cGMP/IEC 62304 and quality systems processes throughout product lifecycle
Partnering cross functionally to ensure product and service conformance with particular focus on Design Controls, Document Controls, Risk Management (per ISO 14971), Production, Service Controls
Assuring compliant process and product documentation, inclusive of Design History, Product, Process and Service documentation in support of product realization and commercialization within the Beckman Coulter quality system
Awareness of current industry standards and regulations and how they relate to internal policies and procedures. Influences interpretation of internal policies and procedures to ensure quality and compliance

Skills

Quality Assurance

ISO 9001

ISO 13485

cGMP

IEC 62304

Design Control

Quality Systems

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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