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Sr. Corporate RA/QA Compliance Auditor (Kloten, Zurich) in Kloten, Switzerland at Danaher

Date Posted: 5/18/2019

Job Snapshot

Job Description

Job ID: DEN000401

About Us

Dental Co About Us: The Dental Platform will become an independent publicly traded company by way of an initial public offering with an anticipated completion in the second half of 2019.  “Dental Co” will become one of the largest and most innovative dental companies in the world.  We are changing the face of dentistry with our differentiated portfolio of products designed to serve every dental professional’s need. It is our mission to make our dentist's work simpler and better connected so more patients are cared for in a shorter time. Our dental brands include traditional consumables and equipment (KaVo Kerr) and specialty products (Ormco and Nobel Biocare).



Description

JOB SUMMARY:  

The Sr. Corporate RA/QA Compliance Auditor will perform internal auditing of Danaher’s MedTech businesses Quality Management Systems in order to ensure compliance to company policies and procedures, as well as, external standards and regulations, including 21 CFR Parts 820, 803, 806, and 807, ISO 13485, MDSAP , Marketing, Advertising and Promotion, ,Medical Device Directives (MDD), In-Vitro Diagnostics Directive (IVDD) Canadian Medical Device Regulations, and other applicable standards and regulations. 

 

ESSENTIAL DUTIES & 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 effectivity of the internal audit program, identify key improvement areas.
  • Assist in the development, implementation and integration of quality systems at regulated Danaher sites.
  • Staying informed 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.

Job Requirements



Qualifications

REQUIREMENTS:

  • Bachelor's degree (B.A. or B.S.) in a science discipline from a four-year college or university and/or training or equivalent combination of education and experience.
  • 5+ years in-depth working knowledge and experience with FDA QSR, 21 CFR 820 and ISO 13485, ISO 14971, PMDA, MDSAP.
    o    Possesses extensive quality systems auditing and associated practices knowledge.
    o    Experienced with CAPAs as an owner and/or approver. 
  •  Ability to travel 50-60% (domestically & internationally).


PREFERRED QUALIFICATIONS:

  • 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.
  • Effective listening skills to gather and clarify information and provide feedback to appropriate stakeholders.
  • Strong verbal, written communication and presentation skills to interface effectively with Director and VPs levels.
  • Possess statistical & data analysis abilities; proficient with Excel & statistical analysis.


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Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.

At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.

Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.