Danaher Corporation Complaint Analyst in Cincinnati, Ohio
Danaher Company Description
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.
The Post Market Complaint Analyst is responsible for executing the Post Market surveillance process for the Mammotome businesses. The Complaint Analyst works closely with cross functional teams, QRA, Sales, Engineering, to ensure product quality and patient safety. This position maintains key activities for compliance to quality systems regulations.
ESSENTIAL FUNCTIONS (ACCOUNTABILITIES/RESPONSIBILITIES)
RESPONSIBILITIES * Manages the complaint record through all phases of the process: evaluation, investigation, reporting and closure as required with interfaces to other roles and department * Ensures effective and accurate product complaint data is procured, documented, routed, resolved and appropriately filed. * Supports regulatory assessment and reporting. * Provides customer follow up and post investigation communication. * Applies critical decision-making skills toward assessing customer complaints and resolution. * Generate, monitor and report on weekly and monthly complaint metrics * Analyzes, assesses and recommends improvements of the complaint management process. * Partners with internal departments to ensure compliance with policies, procedures, federal and state medical device regulations * Effectively questions customers, to capture accurate product and event information. * Support Control of Documents as needed * Controls and issues quality-related documents. * Maintains all document history files. * Operationally executes the document control system (i.e., electronic application). * Provides support during regulatory inspections of the area. * Maintains Regulatory Standards Listing. * Maps Quality processes and writes procedures as needed. * Generates and tracks metrics.
Support Control of Records as needed
* Controls quality records (e.g. storage and retrieval).
* Maintains all record files (internal and off-site).
* Operationally executes record filing system (i.e., electronic application). * Provides support during regulatory inspections.
CRITICAL SUCCESS FACTORS
* Excellent communication skills, both written and verbal
* Ability to gain followership and drive results
* Excellent facilitation skills. Ability to hold individuals attention, create excitement and hold all team members responsible for outcomes.
* Positive attitude and ability to work closely with entire leadership team to drive change, continuous improvement, and engagement throughout the organization
* The capacity to plan, organize, & complete projects on time. Excellent project management skills and ability to juggle multiple responsibilities and deadlines
* Ability to lead teams and drive change in a matrix organization
* Action oriented individual who is highly proactive at solving problems and obtaining results.
* True love of continuous improvement, measuring results and problem solving.
* Team player who can work well across a global organization * Willingness to learn the complexities of working in a Diagnostic industry where compliance to regulation is a must.
Minimum of 2 years of experience with Quality Engineering/Quality Assurance or other regulated business Training and experience in Good Manufacturing Practices and ISO.
EDUCATION High School Diploma
TRAVEL REQUIREMENTS * Must be able to travel up to 5% of the time; both domestic and international travel is required. * Typical work-related travel assignments range 3-5 days, and as such overnight, out-of-town stays are required.
PHYSICAL DEMANDS & WORKING ENVIRONMENT The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Physical demands: While performing the duties of this job, the employee is occasionally required to walk, sit, stand, use hand to finger, handle or feel objects, tools, or controls; reach with hands and arms; balance, stoop, bend, talk and hear.
Work environment: While performing the duties of this job, most work is in an office environment setting. Lighting and temperature are adequate. The noise level in the work environment is usually quiet to moderate.
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, 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.
Job Function: Quality and Regulatory Affairs
Primary Location: North America-North America-United States-OH-Cincinnati
Req ID: MAM000759