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Quality Engineer - Post Market in Cincinnati, Ohio at Mammotome

Date Posted: 1/31/2019

Job Snapshot

Job Description

Job ID: MAM000610

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 Post Market Quality Engineer is responsible for executing the Post Market surveillance process for Devicor Medical Products, Inc. and working closely with cross functional teams, QRA, Sales, Engineering, Operations to ensure product quality and patient safety.
MAJOR RESPONSIBILITIES
  • Drives the complaint evaluation process to lead the organization to focus on most important quality improvement areas.
  • Manages the complaint record through all phases of the process: evaluation, investigation, reporting and closure.
  • Investigation of returned complaint devices.
  • Maintains procedures related to the process.
  • Regulatory assessment and reporting.
  • Provides customer follow up and post investigation communication.
  • Develops and maintains key business relationships to ensure proactive notification and training of associates regarding product, procedure and field activities associated with assigned product line responsibilities.
  • Applies critical decision-making skills toward assessing customer complaints and resolution.
  • Develops risk management plans, reports, and utilize risk management tools such as FMEAs.
  • Applies sound systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues through interactions with project teams and complaint product investigation results.
  • Coordinates and participates in elements of investigations regarding customer complaints.
  • Minimizes customer complaints due to product quality through effective corrective action and preventative actions.
  • Ensures compliance of project activities to appropriate regulations and standards (FDA, ISO, EN).
  • Uses quality tools and practices to establish approval criteria to ensure the identification of quality failure concerns for both internal and external manufactured parts and assemblies through complaint investigation process.
  • Initiates and directs corrective actions to problems relating to product or process quality.
  • Communicates essential Management Review data to senior leadership such as complaint trending and analysis.
  • Provides onsite customer support as a result of product quality issues reported through the complaints process.
  • Other duties as assigned.
    Quality System Knowledge
  • Ensures accurate and timely documentation of complaint resolution.
  • Understands and practices regulatory and compliance procedures.
  • Ensures effective and accurate product complaint data is procured, documented, routed, resolved and appropriately filed.
  • Analyzes, assesses and recommends improvements of the complaint management process.
     
    Industry Knowledge
  • Partners with internal departments to ensure compliance with policies, procedures, federal and state medical device regulations
     
    Effective Questioning and Listening
  • Effectively questions customers, to capture accurate product and event information.
  • Demonstrates understanding and responds appropriately to verbal communications.
     
    Time Management
  • Manages work and time to produce desired outcomes.
  • Other duties as assigned.

Job Requirements



Qualifications

Education:
  • BS/BA degree in a technical, healthcare or business focus preferred.
  • Will consider experience in lieu of education.
Experience:
  • Minimum of three years Post-Market surveillance experience medical device industry required.
  • Potential to develop first-hand knowledge of Company products.
  • Ability to apply core clinical knowledge to technical product troubleshooting and customer complaint processes.
  • Knowledge of Medical Device Regulations.

Diversity & Inclusion
At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page—Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate 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.


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.