Product Surveillance Supervisor
Oakland-Fremont-Pleasanton Metro Area, CA
This position is responsible for ensuring compliance through effective leadership the Customer Complaint process. This position will be responsible for offering direction, coordination, leadership and mentoring of Product Surveillance personnel. Carries out supervisory responsibilities in accordance with the organization s policies and applicable laws.
Responsibilities include planning, assigning, directing, and approving work; addressing complaints, ensure timely and effective processing of complaint records, resolving problems, and assisting with the maintenance of customer complaint activities, adverse event reporting, and post market surveillance reports.
The Product Surveillance Supervisor will work closely the Technical Support, Medical Safety, Medical Affairs, Regulatory, Operations, Commercial, and Service groups to identify, process, and investigate customer complaints, as required by global medical device regulators.
Bachelor s degree and a minimum of 5 years related experience (in life science or other technical discipline preferred) with at least 2 years in a supervisor capacity or Senior role.
Minimum of 2-3 years of experience in FDA regulated medical device manufacturing environment(s).
Demonstrated knowledge of QSR, Canadian MDR, 13485 and 14971 and all other international regulatory requirements with which Allergan complies.
Competent using office software including Database management, MS Word, Excel, Internet Explorer, PowerPoint, Outlook, and other database applications.
Ability to function in a cGMPs controlled environment regulated by the FDA and other competent authorities.
Language and Verbal Skills:
Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, specifications, business correspondence, and procedure manuals in English. Ability to effectively respond to questions from groups of managers, clients, and customers. Ability to clearly and concisely convey project accomplishments, obstacles, issues, and project status.
Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Analytical and Reading Skills:
Ability to read, understand and abide by company procedures. Ability to define problems, collect data, establish facts, draw valid conclusions and report on findings.
The physical demands and work environment described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Most work is performed in an office-like setting. The noise level in the environment is usually low to moderate.