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 firstname.lastname@example.org, or 207-666-8304. We look forward to hearing from you!
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.
- 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.
Currently there are no staff positions reporting to the Quality Engineer. This position may require leadership of assigned employees in the future.
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.
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.
- 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
- 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 (email@example.com) by December 5th.