Vice President Quality Assurance- Kerr in Orange, California at KaVo Kerr

Date Posted: 4/2/2018

Job Snapshot

Job Description

Job ID: KAV002047

About Us

Kerr Corporation, one of the many successful companies owned by Danaher Corporation is a manufacturer of premiere dental consumables sold both domestically and internationally. Since 1891, Kerr has continued to build on its core competencies in developing innovative products for dental restorative procedures. With manufacturing, marketing and sales locations worldwide, Kerr is advancing esthetic dentistry through education and sustainable solutions for the clinician. Kerr's team spirited work environment encourages opportunities for personal and professional growth. Headquartered in Orange, CA., Kerr employs over 2,000 associates worldwide with manufacturing and administration offices located in the US, Switzerland, Czech Republic, and Italy.


Description

Want a career you can “sink your teeth into?”

Kerr Corporation, one of the many successful dental manufacturing companies owned by Danaher, is a top producer of products used by dental professionals in 99 percent of dental practices around the world. Our employees are engaged in creating innovative and highly regarded quality products that add to the well-being, comfort and self-esteem of dental patients globally.

We want to give our associates a reason to smile by creating a workplace where everyone can make a visible difference. We offer competitive benefits including health, dental, vision, and 401k benefits. Come join our team and apply today!

Position Overview:
The Vice President, Quality Assurance will be responsible for the design and achievement of the Professional Consumables organizational goals with respect to quality of products and services across multiple product areas, manufacturing facilities, product design locations and a global supply chain and will include responsibility for the Quality Engineering function. In so doing, the Vice President, Quality Assurance will also ensure compliance with all globally applicable medical device related regulations applicable. The Vice President, Quality Assurance will provide leadership and direction to an international staff, and will be responsible for the selection, motivation and oversight of that staff for the achievement of the department’s goals.

The position serves as a member of the Professional Consumables management team under the leadership of the President, Professional Consumables and reports directly to the Dental Platform Leader of Regulatory Affairs and Quality Assurance . It is essential for the Vice President, Quality Assurance to be able to work in a collaborative and balanced manner with the functional leadership of the Professional Consumables organization and with the Regulatory Affairs leadership of the KaVo Kerr Group while maintaining compliance with regulatory requirements. The position has four direct reports: Director, RAQA, Kerr Europe, Director, QA, Kerr/Dental Medical, Director, RAQA, Professional Consumables, and Senior Manager, Quality Engineering.

The Vice President, Quality Assurance will possess outstanding operational experience and skills, including the demonstrated ability to design quality and regulatory goals and processes, and to provide positive motivation to his/her colleagues in implementing the processes and achieving the goals. With the appropriate operational experience, he/she will understand operating disciplines, how to set appropriate goals, and how to measure and show relevant metrics for all areas involved in the production and delivery of products and services. It will be critical to this individual’s success that he/she has a true collaborative approach to the achievement of goals, be team-oriented and have a hands-on approach

Essential Duties and Responsibilities:
  • Manage external quality and regulatory relationships with the FDA, other regulators and Notified Bodies.
  • Develop, plan and implement company quality objectives and initiatives, resource management and performance criteria.
  • Ensure that the organization’s products meet customer requirements and applicable quality standards.
  • Develop and administer budgets, plans and performance requirements linked to the quality assurance departments.
  • Responsibility and authority to ensure the promotion and awareness of regulatory and customer requirements throughout the organization.
  • Provide quality input to business decisions within the Kerr/Rotary/DM business platforms.
  • Keep company leadership apprised of expected changes to the quality landscape affecting business performance.
  • Direct quality engineering in identifying, recommending, implementing, managing and administering process and software validations.
  • Primary responsibility for hiring, management and training of quality assurance personnel.
  • Primary responsibility for the implementation and management of FDA 21 CFR 820 and ISO 13485 quality assurance programs at various sites.
  • Ensure that all new acquisitions/integrations are in compliance with FDA and ISO requirements while integrating FDA/GMP and ISO programs into these companies as required.
  • Manage Director and Department Managers and personnel in Quality Assurance activities and carry out supervisory responsibilities in accordance with the organization’s policies and applicable laws.
  • Plan, assign and direct work; appraise performance; reward and discipline employees; address complaints and resolve problems.

Job Requirements



Qualifications

Minimum Requirements:
  • Bachelor’s degree in related Science or similar technical disciple (Master’s degree preferred)
  • 10+ years experience in Quality Assurance 
  • 7+ years in a management capacity 
  • Experience in an FDA-regulated industry
Preferred Skills:
  • Extensive knowledge of global quality assurance requirements for medical devices. Prior experience in the dental industry preferred.
  • Excellent analytical and decision making skills, as well as strong communications and people management capabilities.
  • Data-driven decision-maker.
  • Proven managerial and leadership skills, with the ability to lead, motivate and develop staff globally.
  • Expert knowledge of global quality regulations combined with experience in executing complex global quality strategies.
  • Ability to speak effectively before groups of customers or employees of the organization.
  • Current Good Manufacturing Practices
  • Quality System Guidelines
  • ISO13485 Quality Program
  • Risk Management standards including 14971:2012
  • Quality Assurance/Quality Management Systems
  • Statistical Methods
  • FDA Process Validation Guidelines
  • EPA Regulations (preferred)
  • Good Laboratory Practices
  • Scientific Method
  • Mechanical Skills
  • General Chemistry Skills
  • Analytical Chemistry Skills
Kerr Corporation is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law. We maintain a drug-free workplace and perform pre-employment substance abuse testing.
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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 industrial solutions. Our globally diverse team of 59,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $16.5B in revenue last year. We are ranked #133 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 2,000% over 20 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.