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You will be updated with latest job alerts via email$ 100000 - 130000
1 Vacancy
Function as Lead Auditor to schedule plan perform and document internal audits to provide continuous and rigorous assessment of the Cepheid QMS 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 preaudit during audit and postaudit activities including followup.
Maintain uptodate 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 crossfunctional 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 Cepheids QMS of the proposed changes or issue.
Collaborate across the organization at all levels across functional groups and geographic locations including executive management
Bachelors degree in field with 5 years of related work experience or masters degree in field with 3 years of related work experience or doctoral degree in field with 02 years of related work experience.
Possess 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 TAIWANMEDDEVQMS
Excellent verbal and written communication skills
Travel Motor Vehicle Record & Physical/Environment Requirements:
Ability to travel domestically and internationally up to 15% annually; day travel to Fremont Lodi and Newark California . Overnight travel to Lodi California and other domestic and international locations as necessary depending on business need.
It would be a plus if you also possess previous experience in:
ASQ Certified Quality Auditor (CQA) Certification
ISO 9001:2015 process and assessment certification activities
Regulatory Intelligence program
Technical Writing
#LILCS
Join our winning team today. Together well accelerate the reallife impact of tomorrows science and technology. We partner with customers across the globe to help them solve their most complex challenges architecting solutions that bring the power of science to life.
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Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race color national origin religion sex age marital status disability veteran status sexual orientation gender identity or other characteristics protected by law. We value diversity and the existence of similarities and differences both visible and not found in our workforce workplace and throughout the markets we serve. Our associates customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
The EEO posters are available here.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process to perform crucial job functions and to receive other benefits and privileges of employment. Please contact us at to request accommodation.
Required Experience:
Senior IC
Full-Time