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.
EEO Policy Statement
It is the policy of Nihon Kohden America not to discriminate against any employee or applicant for employment because of race, color, religion, sex, sexual orientation, gender identity, national origin, age, marital status, genetic information, disability or because he or she is a protected veteran. It is also the policy of Nihon Kohden America to take affirmative action to employ and to advance in employment, all persons regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, marital status, genetic information, disability or protected veteran status, and to base all employment decisions only on valid job requirements. This policy shall apply to all employment actions, including but not limited to recruitment, hiring, upgrading, promotion, transfer, demotion, layoff, recall, termination, rates of pay or other forms of compensation and selection for training, including apprenticeship, at all levels of employment.
Employees and applicants of Nihon Kohden America will not be subject to harassment on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, marital status, genetic information, disability, or because he or she is a protected veteran. Additionally, retaliation, including intimidation, threats, or coercion, because an employee or applicant has objected to discrimination, engaged or may engage in filing a complaint, assisted in a review, investigation, or hearing or have otherwise sought to obtain their legal rights under any Federal, State, or local EEO law is prohibited.
As CFO of Nihon Kohden America, I am committed to the principles of Affirmative Action and Equal Employment Opportunity. In order to ensure dissemination and implementation of Equal Employment Opportunity and affirmative action throughout all levels of the company, I have selected Melanie Nguyen, Human Resources Representative, as the Equal Employment Opportunity (EEO) Manager for Nihon Kohden America. One of the EEO Manager’s duties will be to establish and maintain internal audit and reporting systems to allow for effective measurement of Nihon Kohden America’s programs.
In furtherance of its policy regarding Affirmative Action and Equal Employment Opportunity, Nihon Kohden America has developed a written Affirmative Action Program which sets forth the policies, practices and procedures that Nihon Kohden America is committed to in order to ensure that its policy of nondiscrimination and affirmative action is accomplished. This Affirmative Action Program is available in the Human Resources office for inspection by any employee or applicant for employment upon request, during normal business hours. Interested persons should contact Melanie Nguyen at 949-268-7725 for assistance.
We request the support of all employees in accomplishing Equal Employment Opportunity.