Quality Systems Manager in Charlotte, North Carolina at KaVo Kerr

Date Posted: 3/14/2018

Job Snapshot

Job Description

Job ID: KAV001777

About Us

KaVo Kerr is a $2.0B OpCo that is a leading, worldwide provider of a broad range of equipment, consumables and services focused on developing, manufacturing and marketing innovative solutions for dental professionals. Within KaVo Kerr is Dental Technologies, which is a $1B business that manufactures and sells products that include 2D and 3D digital imaging solutions, instruments, dental hand pieces, and treatment units. Customers for these products and services include general dentists, dental specialists, hygienists, and educational, medical and government entities. Danaher’s dental products and services are sold directly and through dealer networks around the world.


This position will be responsible for the overall compliance
of the Dental Equipment business in Charlotte with 3rd party Quality Management
System standards, including FDA, ISO, CMD etc. 
The Quality System Manager will be responsible to effectively manage the
CAPA program and support the CAPA owner’s within the broader organization to
effectively plan and execute CAPA projects. 
The Quality System Manager will also be responsible to manage the
Internal Audit Program, ensuring that the Internal Audit Program is well
planned and documented, and that cross-functional auditors are trained and
engaged.  The Quality System Manager will
be responsible to assemble and present Management Review documentation to the
senior leadership team on a quarterly basis and will also assume duties as
Management Representative for the Charlotte facility, supporting all aspects of
the Quality Assurance program and Quality Management System.

Essential Duties and Responsibilities:

  • Manage and Develop the Quality
    Management System – Serving as the local Management Representative.
  • Ensures FDA QSR(GMP), ISO 13485,
    MDD, CMDCAS and/or other national or international standards are continuously
  • Drive Level II PD for the PCKAM
    businesses, including the development of metrics, trending, and CM’s related to
    TTI’s and KPI’s.
  • Manage and maintain the CAPA
    process, supporting CAPA owners with effective planning and execution of CAPA
  • Hosts quarterly Management Review
    meetings, including comprehensive data analysis.
  • Develop and implement a
    comprehensive Internal Audit process to meet ISO, CMDCAS, MDD and all other
    applicable regulatory standards.
  • Ensures the development of new
    products and subsequent change management is conducted in a manner consistent
    with 3rd party regulatory requirements.
  • Serve as the main interface
    between the Charlotte facility and regulatory agencies for all matters
    associated with facility certifications and external audits.
  • This role will identify,
    communicate and implement the key priorities to the organization and exercising
    judgment to determine sense of urgency for priority.
  • Works directly with functional
    leaders and staff members to identify and proactively address areas for
    improvement with in the Quality Management System.

Job Requirements


Minimum Requirements:
  • Bachelor Degree in Engineering, Electronics or relevant field required.
  • 7+ years of experience in Quality Assurance setting.
  • 4+ years of experience in Quality setting with FDA regulations and/or ISO standards
  • 2+ years of experience managing complex projects.
  • Proficient in the use of a computer, MSOffice suite knowledge/experience required.
  • 2+ years of experience in comprehensive ownership/leadership of most aspects of a Medical Device Quality Management System, with a minimum of Class II products - Proven expertise in appropriate FDA, QSR and ISO regulations: design controls, production/process controls, regulatory approval methods.
  • 2+ years of experience in leading subordinate staff to high levels of compliance.
Preferred Requirements:
  • Master degree (MS or MBA)
  • Prior experience serving as the Management Representative and interfacing with regulatory agencies.
  • Past experience acting as Lead Auditor, including certification.
  • Able to successfully work in a structure with off-site leadership.
  • Able to communicate to all levels within the organization.
  • Able to interpret regulatory requirements and establish practical solutions within a dynamic business environment.
  • Experience in leading continuous improvement efforts, in both quality systems and products.
  • Experience with root cause analysis, DOE, statistics, lean manufacturing and six sigma.
  • Knowledge of the process of establishing facility QMS certifications.
  • Track record for successfully driving multi-faceted cross functional projects, including CAPA projects.
  • Cross functional experience with products, engineering processes and manufacturing processes to maintain credibility to communicate and influence change at all levels within the organization.
Kavo Dental Technologies LLC 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.


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 $19.9B in revenue last year. We are ranked #144 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.


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