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 FDA�s 21 CFR Part 820.
- Office environment
- 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.