Sr. Quality Coordinator in Nationwide China at Cepheid

Date Posted: 4/2/2018

Job Snapshot

Job Description

Job ID: CEP001038

About Us

At Cepheid, we are passionate about improving healthcare through faster, more accurate diagnostic tests. With our GeneXpert® System, we’ve taken the most sophisticated molecular technology and packaged it into an automated, easy-to-use format that has quickly become the platform of choice worldwide. From the largest laboratories to small physician offices, our game-changing solution delivers critical answers when clinicians and patients need them most. Through strong molecular biology capabilities and ongoing product innovation, we are focused on developing tests for healthcare-associated infections, sexual health, critical infectious disease, virology, and oncology applications. Come join our vision for a better way and help make life better for us all! For more details, visit us at www.cepheid.com or follow us on Twitter (@CepheidNews).


Description

POSITION SUMMARY:
The role and responsibility of Sr. Quality Coordinator role will include supports Cepheid local quality system compliance efforts in China including conducting quality system internal audits and accommodates notify body’s ISO13485 external audits; monitoring the effectiveness of corrective and/or preventive action; monitoring the trend of customer complaints and coordinates the follow up actions within cross-functional team; coordinating adverse event and product corrective action reporting activities to SFDA; driving the projects triggered by regulatory compliance and QMS requirements of Cepheid.
ESSENTIAL JOB RESPONSIBILITIES:
The incumbent will also be responsible for, but not limiting to the following duties:
• Support quality leadership to develop, maintain and update quality manual, quality plan, quality procedures and instructions
• Conduct internal audits & TPP audits and accommodate external audits; implement and monitor corrective/preventive actions and escalate as appropriate
• Coordinate adverse event and product corrective action reporting activities to CFDA and/or SFDA
• Support Good Supply Practices for Medical Devices and other applicable local regulations
• Monitor trend of customer complaints based on the analysis of customer feedback and coordinates the follow up action within cross-functional team
• Work with individual divisions to provide necessary support to dealers, distributors and customers for quality system and regulatory compliance
• Work with cross functions to drive the projects which triggered by regulatory compliance and QMS requirements
• Assist with execution of field actions pertaining to the products distributed in Big China including Hong Kong and Taiwan as applicable
• Support Cepheid China organization to achieve the business objectives

This description is a summary of principle responsibilities and is not intended to include all duties may be assigned.

WORKING RELATIONSHIPS AND CONTACTS:
• External contacts for this position include CFDA/SFDA officials, dealers, notify body auditors and users/customers
• Internal contacts include all Cepheid staff members in China as well as quality/regulatory staffs from headquarter or other regions
• Working with Cepheid China GM to align on business strategies and achieve the business objectives in China


SUPERVISION RECEIVED AND GIVEN:
The incumbent of this position is mostly responsible for his/her own work as an individual contributor. Only new work is reviewed before issue, all other work is handled independently, reporting status to global quality regulatory and clinical senior vice president initially. Some work requires analysis and use of initiative and independent judgment, such as defining audit findings.

Job Requirements



Qualifications

ESSENTIAL QUALIFICATIONS:


EDUCATION: Degree holder in science, engineering, quality or relevant discipline


LANGUAGE: Excellent English skill, especially for listening and speaking.


COMPUTER: Good command of Microsoft Office: Excel, Word and Power Point


EXPERIENCE: Five years working experiences in quality related areas with science, engineering, project management, quality or relevant discipline is preferred. Experiences in working in In Vitro Diagnostics industry is highly preferred


FUNCTIONAL COMPETENCIES:


• Have knowledge in ISO13485 and experience in quality system auditing is preferred


• Excellent communication skill, maintain frequent contact with internal and external contacts to ensure positive outcomes


• Willing to focus on detailed routine work


• Shows respect for all team members


• Exceptionally strong team player with excellent interpersonal and communication skills


• Begins learning the company businesses and products and how own function impacts business results


• Some leadership skill in coach junior staff within team


• Good coordination skills working with cross functions in China as well as with global Cepheid organization


• Learns customer business needs and takes action to meet those needs


• Learns to analyze business processes and customer requirements


• Continuously learns from experiences, particularly non-routine challenges


• Good project management skill and could continuously pushing the cross function project forward.


TRAVEL REQUIREMENTS:


This position may require business traveling in domestic or international once every quarter, and during peak season (mid-year and year end) the frequency might be increased.



WORK ENVIRONMENT:


This position functions in a general office environment.



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 62,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $16.9B in revenue last year. We are ranked #133 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,300% 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.