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

Quality Engineer

Posted 11/21/2014

The Quality Engineer works closely with Production, Quality and Engineering to continually improve the efficiency and consistency of all manufacturing processes. The position is responsible for monitoring production and inspection processes under the direction of the Quality Manager to ensure adherence to quality system documentation. The position will assist with process troubleshooting and development of solutions to eliminate process problems and measurement of the quality system. The Quality Engineer is also responsible for maintaining a high standard of excellence in all Device Master Record (DMR) documentation in support of the manufacturing process. This person must be uncompromising in his/her promotion of FHC’s core values and commitment to quality and be available to production team for questions and/or concerns.

ESSENTIAL DUTIES AND RESPONSIBILITIES: Other duties may be assigned

  • Develop and evaluate current manufacturing practices, processes and capabilities while facilitating continual improvements through the identification of process issues/concerns in the efficiency and consistency of the same.
  • Identify and implement opportunities for preventive process improvements.
  • Maintain familiarity with relevant portions of the FHC Quality System and perform all duties within its guidelines, specifically those pertaining to calibration, process validation, EC’s and CAPA
  • Collaborate with the Engineering department to design, create, validate and monitor Production and Quality processes and fixturing.
  • Maintain calibration records for all manufacturing tools and fixtures and ensure calibration is current.
  • Work closely with Production Manager to gather feedback and suggestions towards continual improvements for production processes.
  • Maintain familiarity with lean manufacturing tools, statistical process control (SPC) techniques, sampling plan theory and statistical methods with an eye towards continual improvement.
  • Identify, generate and analyze appropriate metrics for the Production processes.
  • Recognize and investigate quality and service problems identified by the FHC quality system under the direction of the Quality Manager.
  • Deliver clear and concise written and verbal communication to management, other team members and end users.
  • Provide reasonably accurate estimations of the amount of work required for completion of assigned tasks. Alert team members as early as possible if estimates change during the development process.
  • Participate in product/project development activities with a focus on ensuring the manufacturability of the final design.
  • Develop and/or assist in the development of 1000, 4000 and 7000 level DMR assembly instructions and the fixturing and processes necessary to support them.
  • Provide initial labor estimates for newly developed bills of material.
  • Closely monitor pilot production runs, intervening as necessary to keep builds on track and facilitate design transfer DMR review activities. Primarily responsible for pilot production validation.
  • Assist with the introduction of, and training for, new prints, processes and instructions.


COLLATERAL RESPONSIBILITIES:

  • Maintain a positive attitude and a passion for excellence in customer service and for promoting the well-being of the company, its products and its employees.
  • Enthusiastically participate in company sponsored community events for the sake of charitable giving in the amount of 4 hours each quarter year.


SUPERVISORY RESPONSIBILITIES:

Currently there are no staff positions reporting to the Quality Engineer. This position may require leadership of assigned employees in the future.


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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk and hear. The employee frequently is required to stand; walk; and use hands and fingers to handle or feel. The employee is occasionally required to sit; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. The employee could occasionally lift and/or move more than 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.


WORK ENVIRONMENT:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the professional, smoke-free work environment is usually moderate.


QUALIFICATIONS:

  •  Excellent verbal and written communication skills
  • Attention to detail
  • Ability to analyze issues and develop corrective and preventive actions that address the root cause
  • Ability to work with others of varied backgrounds and skill sets and assign tasks accordingly

 

LANGUAGE SKILLS: English as primary language; foreign language skills an asset but not required


EDUCATION/EXPERIENCE:

  • Bachelor’s degree in the sciences (engineering preferred) from an accredited technical or liberal arts institution is required.
  • 1-3 years experience in quality engineering or quality assurance/control is required.
  • Experience in sampling plan development, design of experiments, customer complaint handling; process validation, process improvement and statistical process control (SPC) is strongly preferred.
  • Supervisory experience is a plus.
  • Familiarity with ISO/FDA standards is a plus.


Please submit application materials to Lori Manson (lmanson@fh-co.com) by December 5th.

·         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