QMS Quality Engineer at Danaher Corporation

Suzhou, Jiangsu, China

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

Knowledge of medical device quality management systems and regulations (e.g., China GMP, ISO13485)
Ability to establish, implement, maintain, and improve quality management systems
Capability to lead process optimization while aligning with headquarters requirements
Skills in cross-departmental collaboration to promote regulations and GMP execution
Experience in conducting internal/external audits, management reviews, and tracking corrective/preventive actions

Responsibilities

Ensure establishment, implementation, maintenance, and improvement of the quality management system to comply with medical device regulations (e.g., China GMP, ISO13485)
Handle daily quality system operations, including system maintenance, requirement fulfillment, and operational monitoring
Lead process optimization at the Suzhou site to maintain consistency with headquarters
Conduct management reviews, internal/external audits, daily supervision checks, and track audit findings, suggestions, improvements, corrective/preventive actions
Assist in establishing, maintaining, and continuously improving the company quality management system for effective operation
Create and maintain quality system documents to support business needs and comply with standards/regulations
Organize regular internal audits and track rectification of findings to ensure timely closure
Assist in management review meetings and track review actions
Prepare, coordinate, and follow up on external audits, ensuring timely closure of findings
Participate in legal/regulatory reviews, identify applicable laws, and convert requirements into internal QMS processes
Optimize and improve company quality system processes
Conduct quality system-related training to enhance employee quality awareness
Maintain the factory CAPA system, organize CAPA meetings, and drive/follow up CAPA to completion for ongoing compliance
Manage document and record control
Collaborate with site process owners to define process/system improvements for continuous improvement
Communicate efficiently and professionally with departments at all levels to meet quality system requirements
Assist in all site quality system projects and actively participate in team efforts to achieve company quality goals
Complete other tasks assigned by superiors

Skills

ISO13485

GMP

QMS

CAPA

Internal Audit

Management Review

Document Control

Process Optimization

Regulatory Compliance

Training

Corrective Action

External Audit

Quality System Maintenance

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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