Job Id : 23099
Location : Irvine, CA
Company Name : Tekwissen
Job Type : Contract
Industry : Biotech/Pharmaceutical
Salary : $25 - $27 per hour
No. of Positions : 2-4
Required Skills : Supply Chain
Benefits : No benefits are available
Job Description :
- The Complaints Specialist will be responsible for maintaining the quality processes associated with regulatory reporting and its procedures/controls to ensure that all MDR reportable complaints are processed and submitted in accordance with established company procedures and worldwide regulations and standards.
- The candidate will review reportable and potentially reportable complaints from incoming calls, faxes, and emails from all areas of the world.
- The candidate will also ensure adequate information is received to warrant timely reporting, investigation, and closure of reportable complaints, including sound regulatory reporting decisions/justifications for worldwide reporting.
- The individual applies standard practices and procedures, adjusts and correlates data, recognizes discrepancies in results, and follows operations through a series of related detailed steps and processes.
Essential Duties and Responsibilities:
- Responsible for the customer complaints regulatory reporting process (timely submissions, timely closure, health authority requests etc.).
- Responsible for ensuring all required information for a complaint file is obtained and properly documented to make sound regulatory reporting decisions.
- Evaluates all information from a clinical and technical perspective to ensure appropriate Analysis, Investigation, Root Cause, and Quality Engineering review is documented prior to complaint closure.
- Set up complaint meetings and effectively communicate with worldwide complaint groups, as well as other internal departments such as Marketing, R&D, Customer Service and Technical Services.
- Understands basic principles, theories, concepts and techniques related to customer complaints. Escalate critical issues for proper disposition as necessary.
- May receive technical guidance on complex problems, but independently determines and develops approaches and solutions.
- Work is expected to result in the development of new or improved techniques or procedures
- Ensure compliance with the company&39;s Quality System policies and procedures, as well as applicable external requirements and standards, including FDA (21 CFR), ISO 13485, CMDCAS, PMDA and other worldwide regulatory agencies, Johnson & Johnson Environmental, Health & Safety Practices, and other applicable standards as pertaining to medical devices.
- Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance. Support Product Analysis Evaluation if required Performs other duties assigned as needed
Required Education and/or Experience:
- Bachelor’s Degree in technical science discipline plus at least 2 years of recent experience in a medical device complaint or CAPA team, or an equivalent combination of education and experience.
- Working knowledge of international standards and regulatory requirements including but not limited to ISO 13485 and 21 CFR Parts 803 and 820 Technical report writing skills
- Excellent written and verbal communication skills
- Demonstrated attention to detail Ability to work independently as well as in a team environment Strong organizational and analytical skills with the ability to multitask and consistently handle multiple projects with stringent deadlines concurrently
- Proficient in MS Office suite Technical aptitude and ability to explain technical information in a clear and concise manner Analytical problem solving – ability to identify problems, define problem statement clearly and accurately, and apply structured and disciplined methodology to identify data-driven root causes