|Description : |
As the manager of the global complaint handling systems you are an integral and critical member of the global technical support management team establishing and implementing systems, policies and procedures to actively survey global contacts regarding Cepheid products (inquiries through complaints). In addition to analyzing and trending customer complaint and inquiry information, you will propose strategies, processes and metrics for continued improvement and compliance of reporting personnel, complaint escalation, and use of data for post-market review, product and process improvement.
- Lead owner of the current global complaint management system (Electronic data management system).
- Direct the practices and use of current system.
- Oversee modifications and or implementation of new systems as well as global expansion.
- Propose and implement processes in global sites with different types of groups and different levels of Cepheid ownership - fully owned to distributor.
- Manage the review and approval of complaint records.
- Liaise with Quality Systems and Technical Support managers - enforcing best practices and implementing improvements.
- Owner of global technical support complaint handling processes and strategies for continual improvement.
- Implement and manage active surveillance of global complaints on frequencies needed by the business.
- Implement and maintain reports for scheduled complaint, product performance and quality meetings and for distribution to several levels of audiences.
- Conduct analyses and prepare reports for special investigations and escalation activities.
- Review and monitor operations metrics for technical support (i.e. number and type of complaints and inquiries, calls, e-mails, closure times.)
- Manage continued improvement with complaint owners by evaluation and establishment of best practices in recording analyzing and escalating complaints.
- Represent technical support in post market review teams
If interested, please apply online at http://track.tmpservice.com/ApplyClick. … 3-2171-250
|Qualifications : |
- BS in Science, Clinical Laboratory Science or biostatistics, MS preferred.
- A minimum of 10-12 years related experience with a minimum of 5 years direct experience in the areas of complaint management, technical support, quality systems and/or compliance in the health care/ medical device/ diagnostics field.
- Knowledge of the FDA Quality System and Medical Device Reporting regulations and applicable ISO and individual country standards and regulations.
- Demonstrated skills in maintaining compliant complaint handling systems and processes.
- Strong problem solving and analytical skills, risk analysis, demonstrated critical thinking ability.
- Ability to prioritize multiple tasks to ensure compliance with regulations, standard operating procedures and critical business needs.
- Knowledge and application of computer systems for complaint management, data analysis, word processing, reporting, and enterprise/ fulfillment systems.
- Demonstrated progression in responsibility and leadership. Ability to lead in matrix organizations and where direct authority is not assigned.
- Demonstrated ability to succeed in cross-functional teams.
- Demonstrated skill in communicating complex data with analytic findings and recommendations.
- Excellent written/verbal communication and organizational skills.
- Knowledge of molecular diagnostics desired.