Sr Quality Assurance (QA) Specialist at Danaher Corporation

Boulder, Colorado, United States

Apply Now

Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Life Sciences, Diagnostics, Biotechnology, GenomicsIndustries

Requirements

Bachelor’s degree in life sciences preferably in biology, chemistry, biochemistry or related field
3+ years of Quality Assurance experience in a manufacturing industry, biotechnology and next-generation sequencing preferred
3+ years of experience working in medical devices preferred
Experience with quality management systems and regulatory standards such as ISO:9000, ISO:13485, FDA QSR, or cGMP; familiarity with one or more through prior experience in a regulated environment
Proficiency with computers and a variety of software i.e. Microsoft Office Suite, etc
Strong verbal, written, analytical, and persuasive skills and the ability to interact effectively with all levels of employees and management (preferred)
Ability to accept responsibility for the direction, control or planning of a project (preferred)
Experience with SAP, MasterControl, and Maintenance Connection (preferred)

Responsibilities

Provide administration, coordination, and maintenance of key components of the Quality Management System at the Boulder, CO site, including document control, nonconformances, deviations, training and other process control functions
Ensure the timely completion and investigation into Quality event investigations (Nonconformances, Deviations, and support of Customer Complaints)
Complete timely review and release of batch records, inspections, and COA creation for various raw materials, in-process materials, subassemblies, and finished goods in accordance with product specifications
Interact professionally and efficiently cross-functionally with Manufacturing and various support teams; Logistics, R&D, Product Management, Supply Chain Planning, and QC
Implement, maintain, and improve IDT’s Quality Management System in accordance with ISO 13485, 21 CFR 820 and regulatory guidance documents; work with the IDT Global QS team
Participate in internal and external audits, as needed

Skills

Quality Management System

Document Control

Nonconformances

Deviations

Customer Complaints

Training

Process Control

Quality Event Investigations

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