Quality Coordinator at Erbe USA, Incorporated in Marietta, Georgia

Job Description:

Federal Applicant Rights - English

Federal Applicant Rights - Spanish

 

Essential Responsibilities

• Interfaces with the technical service department and field representatives to ensure that complaints are adequately investigated and that the findings are clearly documented. Creates incident information reports and customer response letters.


• Maintains complaint files ensuring appropriate regulatory compliance.


• Provides follow-up and support to field sales personnel regarding re-training needs in connection with complaints of a serious nature.


• Interfaces with field representatives to gather information regarding complaints/incidents that maybe a Medical Device Report (MDR). Tracks complaints/incidents that are MDRs to ensure that filing requirements are met.  Assists in the electronic reporting of MDRs (i.e., helps with submitting documentation to FDA).


• Creates and maintains training files and training documentation for all direct, independent, and distributor personnel; tracks Bloodborne Pathogen and OR Protocol certifications.


• Sees to the control and filing, including the documented removal, of quality records.


• Performs administrative tasks for department as needed including distributing and maintaining controlled copies of quality documents, etc.


• Supports/Evaluates environmental monitoring.


• Reviews all quality documents (i.e., Forms, Policies, SOP’s, STPs, etc.). Sees to the formatting per corporate guidelines.


• Assist with internal audits and audits performed by external auditors at ERBE USA. Evaluates vendor performance.


• Supports quality training initiatives.


• Performs other duties and projects as assigned by management.

 

Supervisory Responsibility

This position is an individual contributor and has no direct supervisory responsibility.

 

Work Environment

This position operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

 

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand, walk; use hands to finger, handle or feel; and reach with hands and arms.

 

Position Type and Expected Hours of Work

This is a full-time position. Days and hours of work are Monday through Friday, 8:30 a.m. to 5 p.m. Occasional evening and weekend work may be required as job duties demand.

 

Travel

This position requires no measurable travel.

 

Required Education and Experience

• High school diploma or equivalent required; some postsecondary education and/or relevant training preferred.


• 1-3 years of experience in an administrative role; experience in a Quality & Regulatory department preferred.

 

Position Requirements

• Excellent verbal and written communication skills are required as are strong interpersonal skills.


• Must be detail-oriented and possess strong organizational skills.


• Must be able to handle a high volume of work while meeting appropriate deadlines.


• Demonstrated high quality computer skills including MS Office, Outlook and some exposure to electronic quality systems.


• Must be able to work independently using experience and judgment to make sound decisions.

 

Competencies

• Problem Solving/Analysis.


• Results Driven.


• Detail Orientation.


• Customer Focus.


• Technical Capacity.


• Communication Proficiency.

 

Additional Eligibility Qualifications

None required for this position.

 

Work Authorization/Security Clearance

Employees must be legally authorized to work in the United States.  Employees must not be specifically barred from working with Federal contracts, government entities or otherwise listed on excluded parties list as maintained by the Federal government.

 

AAP/EEO Statement

Erbe employees and applicants for employment are protected by federal laws, Presidential Executive Orders, and state and local laws designed to protect employees and job applicants from discrimination on the bases of race, religion, color, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, family medical history or genetic information, political affiliation, military service or other non-merit-based factors. These protections extend to all management practices and decisions, including recruitment and hiring practices, appraisal systems, promotions, and training and career development programs.

 

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

 

At-Will Employment

This position description does not constitute a contract or guarantee employment for any specified time.  The company may exercise its employment-at-will rights at any time.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

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