Quality Assurance Engineer at Danaher Corporation

Muskegon, Michigan, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Life Sciences, Biotechnology, DiagnosticsIndustries

Requirements

Bachelor's degree from an accredited University or College, preferably in a Science or Engineering discipline
Multiple years working experience in Quality Assurance/Quality Engineering
Experience in equipment qualifications, process validations, cleaning validations and computer software validations
Previous experience in root cause, corrective action, preventative action and process improvement
Understanding of ISO 9001, Good Manufacturing Practices (GMP), and Good Documentation Practices (GDP) requirements
Ability to travel up to 10% a year
Must have a valid driver’s license with an acceptable driving record
Ability to lift, move or carry equipment up to 10lb frequently, and up to 25lbs infrequently

Responsibilities

Review and approve user requirement documentation (URS), Failure Mode Effect Analysis (FMEA) and equipment Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ), process validation (PV), cleaning validation (CV) protocols and/or Plans and Reports
Assist and approve deviation investigations, corrective and preventative actions (CAPAs), process improvements related to equipment qualification and validation activities
Be the subject matter expert for Change Control on launched products, managing the local Change Management Board
Improve and develop QMS work instructions and cross train as a backup for other QA members
Participate in quality walks and internal audits to ensure compliance with industry standards
Maintain ownership of the Muskegon site Validation Master Plan
Serve as the subject matter expert for the validation strategy

Skills

URS

FMEA

CAPA

Change Control

Validation Master Plan

Deviation Investigations

Process Validation

Cleaning Validation

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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