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Manager, Quality Assurance- Complaint Handling - Microbiology Business in Sacramento, California at Beckman Coulter Diagnostics

Date Posted: 11/19/2018

Job Snapshot

Job Description

Job ID: BEC011721

About Us

At Beckman Coulter, we are dedicated to advancing and optimizing the laboratory. For more than 80 years, we have been a trusted partner for laboratory professionals, helping to advance scientific research and patient care. We do challenging work on a global scale, and are invested in growing our associates’ careers. We embrace continuous improvement, and are passionate about moving science and healthcare forward.

We have a vital role at Beckman Coulter: our focus on innovation, reliability and efficiency has led us to become the partner of choice for clinical, research and industrial customers all over the world.

Beckman Coulter is a Danaher company, operating in two industries: Diagnostics and Life Sciences. 


Description

The QA Manager leads the Complaint Handling Team and will participate in complaint handling activities for the purpose of ensuring compliance with US and international regulatory compliance and medical device reporting requirements, as well as improving the customer experience. 
•Manage the CHU team that receives and processes complaints escalated from internal and external customers related to products manufactured and or distributed and serviced by the company in a manner consistent with all laws and regulations for medical devices.
•Generate and analyze customer feedback (CF) data to improve product reliability and performance for our customers
•Assess complaint information for determination of adverse event reporting and/or vigilance reporting
• Applies standard practices and techniques in specific situations, drives continuous process improvements, and adjusts staffing as necessary. 
•Possess understanding of risk management concepts and is capable of assessing product risks across unit of work
•Identify critical product issues and escalate through the quality system for Field Action, Corrective and Preventive Action (CAPA), Supplier Corrective Action, and/or Stop Shipment activities.
•Independently and collaboratively evaluate information, reports, and data and provide recommendations for process improvements. Works cross-functionally within the quality system and product line management
•Leadership and participation on Post Market projects and routinely share project goals, status, requirements, and deliverables to upper management. Communicate, work cross-functionally and consult frequently with Manufacturing, Operations, Engineering, Service/Support, Sales, Research and Development, Quality, Regulatory and Marketing. Ensure completion of key deliverables
•Primary Subject Matter Expert and key interface with regulatory bodies for Customer Feedback/Adverse Events processes.

Job Requirements



Qualifications

  • Bachelor’s degree with 9+ years in Science or Engineering discipline, or relevant years of Quality/Regulatory Affairs experience
  • Master’s degree with 7+ years in Science or Engineering discipline, or relevant years of Quality/Regulatory Affairs experience
  • Medical Technologist /Clinical Laboratory background preferred
  • Extensive knowledge of domestic and international quality systems and other standards such as FDA, QSR, MDD, CMDCAS, SFDA, JPAL, MDSAP, CLSI, EUCAST, ISO 13485, ISO 14971, World Health Organization or other applicable standards and regulations.
  • Experience leading a cross functional team
  • Ability to drive results, foster teamwork, handle pressure, and provide feedback

 *LI-TH1.



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.