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Danaher Corporation Senior Corporate RA/QA Compliance Auditor in New York, New York

The primary role of this position is to perform internal auditing of Danaher’s MedTech businesses Quality Management Systems in order to ensure compliance with company policies and procedures, as well as, external standards and regulations, including 21 CFR Parts 820, 803, 806, and 807, ISO 13485, all applicable MDSAP countries, Marketing, Advertising and Promotion, Medical Device Directives (MDD), In-Vitro Diagnostics Directive (IVDD) Canadian Medical Device Regulations, and other applicable standards and regulations.

Note: this is a fully remote role. We will consider applicants from any global city.

Essential Duties and Responsibilities:

  • Perform internal audits for the Danaher regulated facilities to the applicable national and International regulations (21 CFR Part 820, ISO 13485, MDSAP, PMDA, etc.).

  • Communicate audit results through closing meetings and audit reports.

  • Provide feedback and guidance to sites CAPA Owners on corrective and preventive actions.

  • Provide support to enhance the efficiency and efficacy of the internal audit program, identify key improvement areas.

  • Assist in the development, implementation and integration of quality systems at regulated Danaher sites.

  • Stay informed on upcoming regulations and standards and gathering industry intelligence through reviews of publications, regulatory conferences, and FDA 483s and Warning Letters issued in order to properly adjust compliance activities at Danaher’s regulated businesses.

  • Support Op-Cos in quality system, and regulatory process improvement projects.

  • Assist in the management of external agency audits and recall efforts.

  • Assist in RA/QA integration, post acquisition, to ensure Danaher’s high standards of compliance.

  • Assist in the development and presentation of training programs for RA/QA and other functional leaders and team members.

  • Assist in corporate RA/QA compliance tracking and reporting activities as directed.

  • Performs special projects at the direction of the Department Management.

  • Facilitates a quality culture and promotes team-work, quality requirements understanding and continuous improvement.

  • Proficient in Audit Report writing skills

Qualifications:

  • Bachelor's degree in engineering, business, or related field of study; science discipline preferred

  • 5 years’ related experience and knowledge of FDA QSR, 21 CFR 820 and ISO 13485, 14971, MDD/IVDR, PMDA, MDSAP, including experience in new EU MDR/IVDR regulations, etc

  • Extensive quality systems auditing and associated practices knowledge

  • Experience with CAPAs as an owner and/or approver

  • Reliable and capable of working with minimal supervision to manage audit planning, execution, and follow-up activities

  • Able to manage controversial issues that may arise from internal audits through constructive communication with cross-functional teams. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily and it will require approximately 40%-60% travel (domestic and international)

When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.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 (https://www.dol.gov/agencies/ofccp/posters) .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 202.419.7762 or applyassistance@danaher.com to request accommodation.If you’ve ever wondered what’s within you, there’s no better time to find out.

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