Quality Assurance Manager at Danaher Corporation

Waltham, Massachusetts, 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, Biotechnology, Medical DevicesIndustries

Requirements

Bachelor's degree in Quality Management, Engineering, Life Sciences, or a related field
Minimum of 5 years in quality assurance within the medical device or related industry
At least 3 years of experience in a managerial or supervisory role
Proficiency in ISO 9001, ISO 13485, and MDSAP standards
Demonstrated ability to analyze data and proficient with analytical methods like Pareto Charts, Control Charts, Statistical Methods, and Sampling Plans
Lead Auditor Certification
Experience leading investigations and CAPAs
Experience supporting validation plans, design, and production provision activities
Experience leading Quality Plans or Continuous Improvement projects to deliver on-time to defined specifications
Willingness to travel 5% (including potential internationally)

Responsibilities

Responsible and accountable for the Quality Management Systems (QMS) at Abcam’s Waltham area site
Assure compliance with applicable regulations, including ISO 13485, 21 CFR 820, ISO 9001 quality standard requirements
Maintain knowledge of existing and emerging regulations, standards, and guidance documents; interpret regulatory rules or rule changes and ensure communication through corporate policies and procedures, and engaging training
Lead Quality complaint investigations and ensure timely closure for identified Corrective and Preventative Actions to improve overall complaint rate performance for all customers in the Americas
Direct management of QA Coordinators to develop capability and enable a high performing, engaged quality team
Lead the Quality deliverables at the site and influence all relevant teams to deliver high performance and meet key QA targets through daily management and weekly reviews
Promote the development of a company-wide culture of quality assurance and understanding of key QMS elements
Oversee an ISO 9001 certified Quality Management System producing research kits and an ISO 13485 and MDSAP certified division producing Class I IVDs, ensuring compliance and excellence
Drive quality improvements for customers across the Americas, fostering a culture of continuous improvement and operational excellence

Skills

ISO 9001

ISO 13485

MDSAP

21 CFR 820

Quality Management System

CAPA

Complaint Investigations

Regulatory Compliance

QMS

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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