Quality Complaint Analyst in Cincinnati, Ohio at Mammotome

Date Posted: 7/21/2019

Job Snapshot

Job Description

Job ID: MAM000676

About Us

At Mammotome, we are committed to providing best-in-class technology to help clinicians accurately diagnose breast cancer. We provide clinicians devices spanning the breast cancer diagnostic care continuum from tissue biopsy to accurate lesion removal, never forgetting that at the heart of each breast cancer diagnosis is the patient. Through our ever-expanding product portfolio we strive every day to improve the patient’s journey and achieve better outcomes. Headquartered in Cincinnati, Ohio, the Mammotome brand is sold in over 50 different countries throughout the world. 



Description

The Post Market Complaint Analyst is responsible for executing the Post Market surveillance process for Devicor Medical Products, Inc. and working closely with cross functional teams, QRA, Sales, Engineering, to ensure product quality and patient safety.

Major Responsibilities 
Product/Process Knowledge 
  • Drives the complaint process.
  • 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.
  • Generate, monitor and report on weekly and monthly complaint metrics
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

Required Education, Experience, Skills
Education:  
  • •         The successful candidate will have one of the following

    o    Post market surveillance experience in the medical device industry

    o    5+ years of clinical nursing experience.

    o    A Bachelor’s degree in Engineering with related co-ops/internships

    •         Demonstrated ability to learn quickly in a medical, clinical or FDA regulated environment


Travel: 
  • Must be able to travel up to 10% of the time.
  • Typical work-related travel assignments range 1-3 days, and as such overnight, out-of-town stays are required.


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 71,000 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 #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 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.
Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.