Analyst II, Quality – 101052 – Valencia, CA

Delivering on the promise of medical innovation begins at Boston Scientific.

By delivering innovative products that help clinicians improve the lives of patients every single day, Boston Scientific makes a profound impact on the quality of medical care around the world. As we continue to transform the field of medical technology, we seek dedicated individuals who possess the integrity and creative spirit needed to thrive in an innovative company. Join a global organization that is fueled by the diversity and talent of its entire workforce.

Analyst II, Quality - 101052 - Valencia, CA - 0300

Job Description:
Primary Function
Boston Scientific Neuromodulation, a leading producer of medical devices for neuromodulation is looking for a CMC Specialist to work in a team environment with members of the QA-Post Market Surveillance group. Specifically, work in a team of complaint specialists in the Complaint Management Center (CMC) who disposition, manage, and close product complaints associated with medical devices. In this role you will work closely with Patient Care and the Complaint Call Center (CCC) areas to process all customer issues and identify complaints, as required by FDA, Canadian, European, and other international regulations related to medical device manufacturers. Maintain all complaint files in accordance to Boston Scientific policies. The position will support post market and clinical studies. Must be able to work well in a team environment, foster team building, proactively communicate project and task status, and operate with a high level of initiative. Possess verbal and written communication skills to communicate effectively with various levels of management in both business and technical communities.

Duties and Responsibilities
·Maintain and follow proper compliance to quality system regulations (FDA Code of Regulations 21CFR part820)
·Establish and maintain complete complaint files and databases for all customer complaints, according to compliant, FDA, and international regulatory and compliance requirements related to the complaint system process
·Review all received complaints to identify if a complaint is reportable under the FDA international requirements. Document decision process for all complaints received
·Complete and submit MDRs and other regulatory reports as needed
·Identify, initiate, and/or perform corrective action activities (CAPA, Non-Conformance) in response to trends and patient based risk
·Conduct investigations, complaint trending, and Product Inquiries
·Perform job duties with general instructions

THIS IS A DEFINED TERM POSITION FOR UP TO 12 MONTHS

Job Experience:
Required Qualifications
·Bachelor’s Degree in English, Health Sciences or related field
·Minimum 2 years of experience reviewing and processing documents

Preferred Qualifications
·Minimum 1 year experience supporting post-market activities in a FDA regulated industry OR certified ISO environment
·Experience processing complaints

THIS IS A DEFINED TERM POSITION FOR UP TO 12 MONTHS

Minimum Education Required: Bachelor

Years of Experience Required: At Least 1 Year

Expected Travel Time: None