Quality Specialist, Customer Feedback##Santa Ana##Ca

Nihon Kohden Irvine , CA 92606

Posted 3 months ago

Job purpose

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.

Required Qualifications

  • 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).

Preferred Qualifications

  • 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.

Working conditions

  • Office environment

  • Minimal travel up to 15%

Physical requirements

  • 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.

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Quality Specialist, Customer Feedback##Santa Ana##Ca

Nihon Kohden