d) at Danaher Corporation

Grens, Vaud, Switzerland

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Life Sciences, Biotechnology, DiagnosticsIndustries

Requirements

Bachelor's Degree required, preferably in microbiology, cell biology, molecular biology, biochemical or chemical engineering, or related field such as Quality Management
Minimum of 10 years working in the pharmaceutical or medical device industry
Quality Assurance/Quality Engineering experience in the medical device industry or Pharma GMP experience in quality assurance
Minimum of 3 years supervisory/management experience preferred
Understanding of medical device manufacturing QMS requirements and regulatory requirements including ISO 13485, ISO 9001, ISO 14971, Medical Device Regulation (MDR) 2017/745, FDA 21 CFR 820, 210 & 211
Exceptional analytical, problem solving & root-cause analysis skills
Excellent organizational, presentation, meeting facilitation and technical writing skills
Experienced in managing project teams and working cross-functionally at global level
Fluent in French and English language
Plus: Previous experience in Quality and/or operational roles across Life Sciences regulated industries
Plus: First-hand experience in preparation, execution and follow-up of regulatory audits

Responsibilities

Lead the site QA team and be part of the extended site leadership team working with cross functional groups at and above site
Ensure full quality and regulatory compliance of the Signy facility and associated franchises
Drive process effectiveness and efficiency at the site
Provide site Quality System Overview training, CGMP orientation and Annual Refresher training, Good Documentation Practices training, and Deviation Writing training
Host customers compliance and site qualification audits

Skills

Quality Assurance

Regulatory Compliance

cGMP

Quality Management

Audits

Deviation Management

Training

Process Improvement

Site Leadership

Cross-functional Collaboration

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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