Careers

Thank you for your interest in a career at FHC! As resumes don't always provide the information we desire from applicants, we ask that, in addition to your resume, you also send a completed application. Click the link below to download an application. You will need Adobe Acrobat Reader to open this file. Please e-mail or fax your completed application to lmanson@fh-co.com, or 207-666-8304. We look forward to hearing from you!

Application For Employment

 

Unique Opportunity

Posted 6/19/2012

FHC has a unique opportunity available for the right individual to help us establish a branch office in Japan. We are looking for an energetic, enthusiastic and resourceful individual with a PhD. in neurophysiology who is familiar with the techniques and uses of our microelectrode recording and stimulating products. This person will provide technical support to our customers, evaluate customer needs and oversee the day-to-day operation of the business. FHC would prefer someone with a US education, and requires that this individual be fluent in Japanese and English.

We are very excited to continue to grow our business into the Pacific markets and are looking for someone to share this passion. If you are interested, please contact Keri Seitz at kseitz@fh-co.com.

 

·         Be very familiar with ISO Quality Management System regulations.

·         Assist Regulatory Affairs Associate with recall notifications and incident reporting, including generation of customer notification, customer contact lists, follow-up notifications and reporting to regulatory bodies. 

·         Provide documents to distributor and regulatory agencies for registration of products worldwide.

·         Prepare documents for legalization/apostille; corresponds with consulates or other agencies.

·         Prepare and maintain priority lists for pending registrations, updates progress and communicates delays.  Submits report to QSO & Quality & Regulatory Affairs Manager on a monthly basis.

·         Provide documents to distributor and regulatory agencies for registration of products worldwide

·         Audit completed ECs weekly so as to provide input to the QEST for the weekly RC meeting preparation.

·         Monitor emails received through FHC’s quality email address and open RNs when necessary and/or forward the email to the appropriate individual if not a customer complaint (e.g. request for quotation, request for technical assistance etc.)

·         Assist the Regulatory Affairs Associate in the review & approval of routine sterilization load documentation for the release and validation of sterile product.

·         Assist in the review, preparation, and maintenance of regulatory documents in support of project development of new products and maintenance of existing products.

·         Assist the Regulatory Affairs Associate in the preparation, review, and revision of protocols, final reports, standard operating procedures, forms, manuals, technical files, and marketing materials.

·         Primarily responsible for the submittal and maintenance of FHC’s FDA Establishment Registration, Small Business Designation renewal, Certificates to Foreign Government (CFGs), MDD Product Lists for the EU, Medical Device Listing spreadsheet.

·         Assist QSO in the preparation of responses to external audit findings.

·         Act as an internal auditor and assist QSO in preparation and organization of internal audit documentation before, during and upon conclusion of the audit annually.

·         Assist in the revision of existing and new quality documents.

·         Must be familiar with FHC’s CAPA software application and the rules for its use and assist employees with CAPA processes (RNs, NCs, ECOs, etc) and other issues related to the Quality Management System.

Actively participate in and set an example for other employees regarding maintenance of an overall company-wide quality ethic program, by ensuring other departments have the necessary information to export product in compliance with regulatory protocols