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 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
The essential requirements of the job include:
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.
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, TAIWAN-MEDDEV-QMS
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 required. 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
Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com.At Cepheid we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part of the time at the Company location identified above and part of the time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Cepheid can provide.The salary range for this role is $100,000 – $130,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.This job is also eligible for bonus/incentive pay.We offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.#LI-LCS
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