Pioneering Therapies, Transforming Lives. What does it mean to be part of the Thoratec Team? It means working in a fast-paced environment that inspires you. It means collaborating on projects that literally save patients' lives. We have an incredible opportunity for a Post Market Surveillance Data Analyst to work with our innovative Customer Affairs team in Pleasanton.

The Post Market Surveillance Data Analyst will be responsible for the data analysis of all facets of customer complaint handling in order to assure that the Company is maintaining effective customer complaint reporting and trending.  The duties for this position require a thorough knowledge of the development and maintenance of systems which track and measure all aspects of customer complaints in accordance with regulatory requirements.  This position requires excellent communication skills, initiative, ingenuity, and statistical analysis.  Additionally, this role provides guidance system improvement suggestions to Sr. Management in order to ensure effective data and reporting analysis, regulatory reporting and timely customer communication are continuously maintained and improved.  

Responsibilities:

This position is responsible for, but not limited to, the following:

• Conducts and may oversee the analysis of data on a regular basis and escalates trends and/or significant findings as necessary.  Actively participates in understanding root cause and the identification of actions required to drive resolution as appropriate.  Monitors and reports on the effectiveness of corrective actions.
• Provide various forms of statistical data analysis and presentations for both internal and external customers.  This may include analysis or presentations such as management review, operations review and/or quality review.   This position will require conducting research, verification and validation of all data sources.  
• Assist Regulatory Affairs with reporting requirement requests from regulatory agencies (FDA, Notified Body, Distributor, etc.)
• Assist CDQ Management in the establishment of failure mode and root cause categories, determination of trends, and generation of routine and special reports for Management Review, DASH, Monthly Reports, Trend Analysis, PDP data and customer presentations.   Conduct additional data gathering and data analysis when required.  Regularly conduct reviews and reports on the effectiveness of corrective actions to prevent future occurrences.

·      Interface with other departments, such as Sales/Clinical, Clinical Affairs, R&D, Manufacturing Engineering, Technical Services, Quality Assurance, etc. to obtain additional information to ensure trends and complaint reporting information is accurate.  Leads and/or participates in cross-functional meetings as necessary to drive actions associated with product quality improvements.

• Apply innovation skills to improve the input content and the output (queries, reports, etc.) of the complaint database.
• Assist in technical writing of customer notifications.
• Suggest strategies to improve complaint processing cycle time, customer complaint processing, investigations and/or customer response processes.
• In addition to the unique responsibilities of the Data Analyst, this position is also responsible to provide back up support for the CDQ Compliance Manager with the presentation of data at management review and/or other management meetings. 
• Other duties/projects as assigned by Supervisor.

Minimum Qualifications:

• Master’s of Science degree preferred, or equivalent combination of education and experience.
• 5 years of experience in data analysis and trending.
• Expertise in scientific analytical methods including: statistics, technical writing and database management.

Additional Qualifications: 

• Proficiency with MS Office and software programs for generating reports, presentations and statistics. 
• Effective interpersonal skills in working with teams to accomplish assigned objective.
• Excellent verbal and written communication skills.
• Excellent planning and organizational skills required. 
• Demonstrated strong analytical and problem solving skills.
• Quality-Focused, Attentive to Detail and Results-Oriented.
• Flexibility to work as a self-starter in a fast-paced, fluid environment with minimal supervision.

Why work for us?

For more than 30 years, Thoratec has been committed to developing advanced medical technologies to improve patient survival and quality of life. Thoratec provides the broadest mechanical circulatory support portfolio to treat the full range of clinical needs. From acute to chronic heart failure, Thoratec offers proven device-based therapies to provide a new beginning for patients and their families. We value people who are passionate about collaboration, creativity, and quality. We give back to our community and help people live healthy lifestyles through support, education, involvement, and participation.

Thoratec employs more than 700 people worldwide. We are based in Pleasanton, California, with facilities in Burlington and Waltham, Massachusetts; Sunnyvale and Rancho Cordova, California; Cambridgeshire, UK; and Zurich, Switzerland.

Thoratec Corporation is an Affirmative Action/Equal Opportunity Employer.