Lead QA Specialist– QMS & Localization at Danaher Corporation

Shanghai, Shanghai, China

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Medical Devices, Life SciencesIndustries

Requirements

Knowledge of GSP-related affairs for medical devices
Experience supporting localization projects from a quality perspective in China
Ability to lead or contribute to post-market QA activities and internal/external audits
Capability to drive continuous improvements, such as timely delivery of CAPAs and maintaining the QMS
Skills in providing and reviewing Quality Agreements (QAA) for commercial teams and customers
Ability to communicate with the Global Regulatory Affairs team on CCN-related and Hazardous Chemicals issues

Responsibilities

Manage GSP-related affairs for Cytiva medical devices
Support the line manager in delivering successful localization projects from a quality perspective in China
Lead or contribute to post-market QA activities and internal/external audits, focusing on driving continuous improvements such as timely delivery of CAPAs and maintaining the QMS
Provide and review Quality Agreements (QAA) for commercial teams and customers in a timely manner
Communicate with the Global Regulatory Affairs team to support local customers on CCN-related and Hazardous Chemicals issues
Perform other duties as assigned by the manager

Skills

QMS

GSP

CAPA

Audits

Quality Agreements

Localization

Post-Market QA

Regulatory Affairs

Hazardous Chemicals

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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