Quality Specialist, Customer Feedback will be responsible for processing customer feedback regarding products and regulatory reporting to ensure that all reportable complaints/incidents are processed and submitted in accordance with established company procedures and worldwide regulations.
Essential Functions and Basic Duties
Overseeing the product complaint system by leading and managing product complaint investigations, performing data analysis and trending of complaint information to proactively detect trends and taking appropriate actions in a timely manner.
Keeping the complaints database updated by accurately entering data on a real-time basis as soon as factual information is obtained.
Ensuring complaint related investigations are clear, concise, and science-based by reviewing and approving such investigations.
Evaluating all information obtained from both a clinical and technical perspective to ensure appropriate Analysis, Investigation, Root Cause Determination, and Final Outcome is documented prior to complaint closure.
Follow-up on Corrective Actions derived from investigations through to completion.
Evaluating assessment received from subject matter experts.
Escalating potential Quality issues to Management.
May also include generation and issuance of closure letters to business partners/complainant.
Adhering to all company policies, procedures and business ethics codes.
Other duties as assigned.
Respiratory Therapist (CRT, RRT) with 3-5 years relevant experience.
Must be computer-savvy and well-versed in Microsoft Office products.
Strong technical writing and verbal communication skills with the ability to explain technical information in a clear and concise manner.
Understanding of Problem-Solving Methodologies.
Great attention to detail with excellent organizational and coordination abilities.
Self-directed with the ability to work both independently and in a team environment with good project management skills.
Ability to function in a fast-paced and deadline driven environment.
Fluent in English (fluency in other languages are a plus).
Prior work experience in the medical device industry in a Quality Assurance role is a plus.
Working knowledge of US FDA (21 CFR 820, 803, 806), Quality System (ISO 13485) and EU Medical Device regulatory requirements.
Good understanding of quality system requirements such as ISO 13485 and FDAs 21 CFR Part 820.
Minimal travel up to 15%
Must be able to type using the keyboard of a computer.
Must be able to talk, listen and speak clearly on the telephone.
Must be able to lift and carry up to 30 lbs.