Sr Manager Quality Assurance at Danaher Corporation

New Brighton, Minnesota, 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, Biotechnology, HealthcareIndustries

Requirements

Bachelor’s degree in Life Sciences, Engineering, Operations, or a related field; advanced degree preferred
8+ years of progressive experience in operations quality assurance, with exposure to QMS and regulatory affairs in regulated industries (e.g., medical device, pharmaceutical, biotech, food manufacturing)
Demonstrated leadership experience managing operational quality teams and cross-functional projects
Strong knowledge of operational QA methodologies, nonconformance management, and process improvement tools (e.g., CAPA, Lean, Six Sigma)
Familiarity with ISO standards (ISO 13485, ISO 14001) and regulatory requirements (FDA, EMA, etc.)
Exceptional analytical, communication, and organizational skills
Up to 20% travel may be required including international travel

Responsibilities

Lead, develop, and manage the Operations QA team to ensure consistent quality practices across manufacturing, warehousing, distribution, and supply chain activities
Oversee in-process quality controls, release procedures, and management of nonconforming materials
Monitor and analyze operational quality metrics, identifying trends and implementing corrective or preventive actions as needed
Ensure timely investigation and resolution of deviations, complaints, and CAPAs related to operational output
Work closely with production and engineering to implement and sustain process improvements that enhance product quality and operational efficiency
Lead audit preparation, execution, and response activities (internal and external)
Support ongoing QMS maintenance, with responsibility for selected QMS elements such as document control, internal audits, management reviews, and QMS training

Skills

Quality Assurance

Quality Management System

QMS

Regulatory Compliance

Operations QA

Manufacturing Quality

Nonconforming Materials

Quality Metrics

Process Quality

Supply Chain Quality

Team Leadership

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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