Job Description

• Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
• Creates, revises, and implements quality standards as well as procedures [i.e., Standard Operating Procedures (SOPs), etc.] for Erbe USA's Quality Management System as an initial importer and distributor of medical devices in the United States.
• This includes updating all Systems to new/revised requirements by FDA.
• Supports monitoring and maintaining quality related information.
• This includes Reports (ECRs), Controlled Documents, Master Document List, etc.(through to in servicing activities).
• Assist in establishing and maintaining a system to electronically control quality related documentation including SOPs, Standard, etc.
• Supports the training of Erbe personnel and agents.
• Reviews as applicable and as necessary product specifications (e.g., dimensional aspects, functions/features, packaging, labeling, etc.) and product testing (e.g., biological testing, performance testing, etc.) involved with products to be distributed and in distribution by Erbe USA.
• Assist in FDA Regulatory Submissions [e.g., 510(k)s, etc.
• To meet regulatory requirements and laws.
• Provides input to addresses Request for additional information by FDA.
• Helps as needed with FDA Regulatory Filings [e.g., Medical Device Reports (MDRs)] to meet regulatory requirements and laws.
• Assists in performing internal and external audits as well as supports the management of audits of Erbe USA from external personnel/organization.
• Supervisory Responsibility.
• This position is responsible for managing the sales representatives in their territory.
• This position operates in a professional office environment and routinely uses office and computer equipment typical of similar positions.
• The position is also exposed to all manner of products in the company's portfolio.
• 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.
• The employee frequently is required to lift and/or carry up to 20 pounds.
• Please refer to the Position Analysis/Physical Activities Checklist on file in Human Resources.
• Days and hours of work are typically Monday through Friday with substantial variety in start and finish times.
• Occasional evening and weekend work may be required as job duties demand.

• Bachelor's degree(s) in engineering, science, or related area of study required.
• Clinical setting experience (intern and/or work) required.
• Excellent verbal and written communications required; strong facilitation and interpersonal skills required.
• Demonstrated computer skills to successfully use MS Office, Outlook, etc.
• Electronic quality systems from Erbe Electromedicine GmbH.
• Must be detail-oriented and produce high quality work in a high-volume environment.
• Must be able to handle confidential information in an appropriate and professional manner.
• Problem Solving/Analysis.
• Detail Orientation.
• Customer Focus.
• Technical Capacity.
• Communication Proficiency.
• While performing the duties of this job, prolonged periods of sitting at a desk and working at a computer are routinely required.
• 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.

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