Senior Quality Systems Specialist at Danaher Corporation

Sunnyvale, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Diagnostics, Healthcare, BiotechnologyIndustries

Requirements

Bachelor’s degree in field with 5+ years of related work experience or master’s degree in field with 3+ years of related work experience or doctoral degree in field with 0-2+ years of related work experience
Significant knowledge of domestic and international quality systems standards and regulations including, but not limited to, 21 CFR Part 820, ISO 13485, MDSAP country related requirements TGA, ANVISA RDC 665, CMDR, MHLW MO 169, IVDD, IVDR, NMPA, TAIWAN-MEDDEV-QMS
Excellent verbal and written communication skills
Ability to travel domestically and internationally up to 15% annually; day travel to Fremont, Lodi, and Newark, California required. Overnight travel to Lodi, California and other domestic and international locations as necessary depending on business need

Responsibilities

Function as Lead Internal Auditor to schedule, plan, perform, and document internal audits of Cepheid’s Quality Management System (QMS), providing continuous and rigorous assessment to identify and implement improvements and ensuring that all internal audit findings are closed in a timely manner with effective corrective action
Participate in external audit management (e.g. FDA, ISO, Danaher Corporate, foreign governments), in either a supporting or lead role, related to pre-audit, during audit, and post-audit activities including follow-up
Maintain up-to-date knowledge and ensure compliance with local, state, and federal regulations and standards including compliance with Food & Drug Administration (FDA), ISO 13485, European Union In Vitro Diagnostic Regulation (IVDR) as well as other applicable global regulatory requirements, including Medical Device Single Audit Program (MDSAP) participating regulatory authorities
Provide cross-functional compliance support for global QMS and Intracompany Quality Agreement requirements. Function as SME for compliance related topics, including the assessment of the overall impact to Cepheid’s QMS of the proposed changes or issue
Collaborate across the organization at all levels, across functional groups and geographic locations, including executive management

Skills

Quality Management System

Internal Auditing

Lead Auditor

FDA Audits

ISO Standards

Corrective Action

Audit Planning

Audit Documentation

External Audit Management

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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