The Complaint Analyst Contractor is primarily responsible for post-market surveillance activities including coordinating the complaint handling process, reporting to the appropriate regulatory authorities, and coordinating activities related to potential recall investigations and field safety corrective actions.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:
Coordinates complaint investigations to determine accuracy of customer report, determine responsibility for errors, and request appropriate corrective actions. Coordinates complaint handling process in accordance with Federal (US), EU, Canada, Japan, and other international regulations and company policy by performing the following duties himself/herself or through subordinates or designees:
Converses or corresponds with customer and other company personnel, such as sales representatives, marketing and/or engineering personnel, customer service, manufacturing personnel, and service and repair personnel, and examines records such as manufacturing records, design control records, distribution records, to obtain facts regarding customer complaints and returns.
Investigates medical device complaints and analyzes returned products for cause(s) of failure and reports on findings. Related activities include, but are not limited to: Examination of returned product to determine accuracy and root cause of complaint; Consultation with appropriate Engineering personnel, as appropriate; Recommendation and implementation of changes based on failure analysis findings
Uses sound judgment and independent thinking in decision making to determine whether a complaint is a reportable event under the appropriate regulations, and notifies the appropriate regulatory authorities as required; Convenes Clinical Review Board as appropriate.
Applies statistical methods for analyzing data to evaluate complaint and failure trends.
Keeps management team abreast of significant issues or developments identified during complaint handling activities and actions being taken to improve the situation, including complaint trends.
Assists Purchasing with vendor quality issues, as appropriate.
Advises management on potential recall decisions and assists Regulatory management with coordinating activities and reporting related to product recalls.
Performs internal quality system audits, including product and/or process, for compliance to domestic and international regulations/standards and document results for management review, as assigned.
Reviews and approves CAPA activities and monitors the success and effectiveness of completed corrective actions to ensure that regulatory requirements are met, as assigned.
Maintains a working knowledge of government and industry quality standards.
Other duties within regulatory may be assigned.
This job has no supervisory responsibilities.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Additional requirements include: demonstrated strong writing and communication skills; strong attention to detail and ability to multi-task; ability to learn and stay abreast of regulations pertinent to medical devices; and ability to function well as a member of the team and build relationships between RA and other areas of the organization.
EDUCATION AND/OR EXPERIENCE
Associate’s degree or one to two years related experience and/or training; or equivalent combination of education and experience is required. No formal complaint analyst or regulatory experience required, two years preferred. For consideretion, please, refere to dice #1347
San Francisco, CAContact