Staff Quality Assurance Engineer at Danaher Corporation

Indianapolis, Indiana, United States

Apply Now

Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Life Sciences, Diagnostics, BiotechnologyIndustries

Requirements

Working knowledge of ISO 9001 & ISO 13485 standards, 21 CFR Part 820, EU IVDR regulation, and similar global regulations (MDSAP, etc.)
Bachelor’s Degree (minimum) in engineering or other science or related field; or equivalent experience required
7+ years’ experience (or 4+ with master’s degree) in engineering, manufacturing and / or quality systems (ISO 9001), medical device (ISO 13485), pharmaceutical, related life sciences or other regulated industries
Effective leadership, communication, interpersonal, and problem-solving skills
Travel requirements < 20% of the time, domestic and international (overnight travel may be required)
Be able to occasionally lift and/or move up to 40 pounds

Responsibilities

Represent Quality Assurance or lead cross functional teams tasked with business-critical initiatives ranging from quality improvement projects to new product transfers and launches
Apply insight of current industry standards and regulations and how they relate to internal policies and procedures; influence interpretation of internal policies and procedures to ensure quality and compliance
Design and deliver training programs on cGMP, GDP, and other quality standards; ensure training effectiveness through assessments and retraining strategies, maintaining alignment with quality, regulatory and internal requirements
Coach teams with application of ISO 9001/13485/cGMP/MDSAP and quality systems processes throughout product lifecycle
Own quality related processes, guide cross-functional teams through Beckman’s quality management system requirements, and ensure product quality for Beckman’s customers

Skills

Quality Assurance

Quality Management System

Cross-functional Leadership

Quality Improvement

Product Quality

Regulatory Affairs

Manufacturing Quality

Process Ownership

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.

Land your dream remote job 3x faster with AI

Try Jobo Free