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Quality Assurance Manager in Sturtevant, Wisconsin at Ormco

Date Posted: 3/12/2019

Job Snapshot

Job Description

Job ID: ORM001538

About Us

Since 1960, Ormco, one of the many successful companies owned by Danaher Corporation, has been developing, manufacturing, and marketing a broad line of orthodontic appliances and related products for sale in the U.S. and abroad. Ormco provides orthodontists with brackets, wires, adhesives, and ancillary supplies used through the course of treatment.

Ormco believes the direct contact of its sales force with orthodontists facilitates the identification and verification of market trends and new product opportunities. Ormco works closely with orthodontists to improve existing products and develop new products primarily through its Champion programs in which selected orthodontists assist Ormco in designing, developing and ultimately educating users on new product and technique innovations.


Description

Summary: The Sr. Quality Assurance Manager will primarily be responsible for managing the Quality Assurance function and staff for AOA in Sturtevant WI to drive the continuous quality improvement process across the business.  The Sr. Quality Assurance Manager will also serve as Management Representative, acting as the crucial link between AOA, its products, and regulatory authorities, including the US Food and Drug Administration (FDA), local, state and international agencies.  The Sr. Quality Assurance Manager also supports other functional areas to ensure all products and processes comply with the appropriate US and International licensing, marketing and legal requirements of medical devices. The Sr. Quality Assurance Manager will have the combined scientific, legal and business knowledge, to ensure that products are developed, manufactured or distributed to meet all applicable requirements.

Essential Duties and Responsibilities:

  • Ensure that the company's products and processes comply with the US Food and Drug Administration (FDA), local, state, and International requirements and regulations.
  • Manage subordinate staff to ensure all functions of Quality Assurance are consistently in compliance with regulatory requirements and corporate standards.  The responsibilities of this function include managing the Complaint process, quality engineering function, document control function, QC and calibration processes.
  • Lead and maintain the local quality management system.
  • Partner with and advise all functional areas, as well as executive management on updated regulatory requirements.
  • Work with new product development teams to ensure quality and regulatory compliance throughout the advanced development process, and ensure QA deliverables are met in support of project requirements.
  • Assist Operations with process development and testing to ensure product quality and compliance throughout product realization.
  • Act in capacity of Management Representative for the organization.
  • Lead the continuous quality improvement process across the business by utilizing trend data and the CAPA process; collect and analyze data in an efficient manner in order to make sound decisions and suggestions to support continuous improvement.   
  • Lead internal audits and assist with supplier quality programs.
  • Performs other duties and task as assigned by supervisor/manager


Job Requirements



Qualifications

Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

REQUIREMENTS: 

  • BS in Engineering or related is desirable. A combination of education and 10+ years of experience in QMS in the medical device industry may be considered in lieu of a degree.
  • Five years as a Quality Management System representative in medical device or related field required.
  • Advanced proficiency required in the use of MS Office suite including Outlook, Access, Word, Excel, PowerPoint. 
  • Proven Managerial leadership experience in communicating with and leading subordinate staff to achieve goals/objectives, as well as high levels of compliance.  
  • Proven track record of creating followership within Quality Assurance and across other functional areas. 
  • Broad experience in implementing quality systems across all aspects of the FDA/ISO requirements, including Design Controls, Process Controls, Purchasing Controls, Change Control, etc.
  • Past experience in leading continuous improvement efforts, in both quality systems and products, and driving sustainable improvements.
  • Must be able to apply problem solving mindset in various settings.
  • Able to successfully work in a structure with off-site leadership.
  • Able to communicate to all levels within the organization.
  • Strong leadership and communication skills.

PREFERRED:

  • Experience with root-cause analysis, DOE, statistics, lean manufacturing and six sigma preferred.
  • Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Strong planning abilities.
  • Previous experience with Oracle and Master Control preferred.

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The noise level in the work environment is usually moderate to high.

PPE- Safety Glasses will be worn by all personnel in production areas or where designated.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available at: http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf.

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Danaher Corporation Overview

Danaher's Dental Platform is a $3B global business focused on all aspects of dental care.  With the intention to spin-off the Dental Platform to become its own public company 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).