This site uses cookies. To find out more, see our Cookies Policy

Director of Quality in Cincinnati, Ohio at Mammotome

Date Posted: 12/2/2018

Job Snapshot

Job Description

Job ID: MAM000558

About Us

In December 2014, Devicor® Medical Products, Inc. was acquired by Leica Biosystems, part of the Danaher family of companies. Leica Biosystems is the global leader in anatomic pathology solutions and automation, striving to advance cancer diagnostics to improve patients’ lives. The combination of the two companies uniquely positions us to develop integrated patient-to-pathology solutions for the diagnosis of cancer.

Headquartered in Cincinnati, Ohio, the Mammotome brand is sold in over 50 different countries throughout the world. Mammotome remains committed to its heritage of advancing technology for early detection of breast cancer, providing support and education for clinicians worldwide, and offering breast care information for patients.

Devicor Medical Products, Inc. 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.

All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check.


Description

The Director of Quality leads the Quality Assurance function for Devicor Medical Products, Inc. and all globally served markets, participates in all planning activities, and is as a key member of the Quality and Regulatory Affairs Leadership Team. This position works closely with Research and Development, Sustaining Engineering, Supply Chain, and Manufacturing regarding supplier selection, component qualification, material selection, clearance for use, and procured finished product quality decisions, which may have significant impact on the business.  
essential functions (ACCOUNTABILITIES/RESPONSIBILITIES):

Design Quality Assurance
  • Leads Quality Engineering support for design and changes, including incorporation of new products and acquisitions into the product portfolio. 
  • Responsible for Quality oversight for validation activities. 
Manufacturing Quality Assurance
  • Leads Quality Engineering and technical support for product realization and market release for both Contract Manufacturers and the Tijuana manufacturing plant.
  • Implements and maintains policies and procedures to govern supplier quality on procured devices.
  • Ensures contract suppliers comply with an ISO certified quality system (ISO 13485), as well as applicable regulations and standards (e.g. FDA, CMDR, JPAL).
Biological and Technical Quality Assurance
  • Leads technical direction and compliance for sterilization, cleaning, materials, and biocompatibility. 
  • Implements and maintains sterilization process qualification policies and procedures which comply with governing regulations and standards (e.g. ISO, AAMI).
  • Trains staff and key personnel in order to attain strategic objectives as well as validating of sterilization processes, equipment, and procedures required for the delivery of sterile product. 
Supply Chain Quality Assurance
  • Responsible for Quality input to supply chain activities, warehousing, storage, distribution, service and repair and traceability. 
  • Ensures that both the Devicor Medical Products, Inc. Service and Repair Center and Warehouse operations comply with an ISO certified quality system (ISO 13485), as well as applicable regulations and standards (e.g. FDA, CMDR, JPAL).
Quality Management System
  • Responsible for all Quality Engineering activities and the creation of team SME’s for audits, complaint handling and investigation, CAPA, statistical validation, audit management, and other elements under the QMS.
Leadership 
  • Designs and implements key control plans and serves as a liaison role to interface with external suppliers.
  • Responsible and accountable for technical release and non-conformance determination. 
  • Demonstrates responsiveness to business needs and motivation of diverse, cross-functional teams, including influencing both internal and external members to achieve positive business results. 
  • Provides leadership needed to instill a team-oriented and results-driven team.
  • Responsible for managing the activities of direct reports and ensuring the organization’s abilities continue to improve through individual development and organizational capabilities. 
  • Leads staff performance management activities to improve capabilities and skills using regular objective setting and review process, performing appraisals and coaching of individuals on development plans.
  • Hires, trains, and manages department staff and activities to ensure high performance, accountability, interdependence and collaboration. 
Other
  • Responsible for the generation of metrics for all areas and levels of responsibility. 
  • Uses the Quality Management System and develops appropriate processes for consistent, technical, risk-based decision making. 
  • Supports product introductions in all markets.
  • Other duties as assigned.
Scope/Role Dimensions 
  • Manages departmental spending to the established budget.
  • Direct reports may include Supervisors and Managers.

Job Requirements



Qualifications

Experience
  • Minimum of 10 years of experience in medical device quality management required.
  • History of success in initiating change and achieving objectives.
  • Successful track record working in a matrix/collaborative environment.
  • History of effectively managing change through organizational restructures and building a strong Quality Management System for sustainability.
Education
  • BA/BS degree in a technical field (i.e., Engineering, Physical Sciences) required.
  • Advanced Degree in field is desirable but not required.
  • Professional certifications (i.e., CQM/OA, CQE, AAMI) strongly preferred.

TRAVEL REQUIREMENTS/WORK ENVIRONMENT and PHYSICAL DEMANDS:
Travel
  • Must be able to travel up to 25% of the time; both domestic and international travel are required.
  • Typical work-related travel assignments range 1-5 days (overnight, out-of-town stays are required).
Work Environment And Physical Demands
  • Typical office environment – accommodations will be evaluated where needed.



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 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% 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.