SUMMARY:

The role of the Quality Engineer Level 1 is an entry-level engineering professional responsible for supporting the development, implementation, and maintenance of quality systems and processes within the manufacturing environment. The Quality Engineer assists in investigating product and process issues, analyzing data, supporting root cause analysis, and implementing corrective and preventive actions to ensure compliance with quality standards and customer requirements.

PRIMARY RESPONSIBILITIES

(INCLUDE

BUT NOT LIMITED TO

):

▪ Perform in-process and/or final quality control verification using measuring, inspection and test (MIT) equipment.

▪ Provide back-up support for QA Inspection/Metrology functions (Calibration control).

▪ Key quality representative in material review (non-conforming product) and supplier quality control.

▪ Collect, record and present quality control data in support of production and test functions.

▪ Implement and maintain Key Process Indicators (KPI) metrics in support of Quality G & O's.

▪ Deliver QA data feedback to production floor and management.

▪ Support the introduction of new products, processes and improvements in support of production, inspection and test operations.

▪ Review, update and process documentation to meet company standards and customer requirements.

▪ Evaluate and approve data or documentation in support of QA/QC/production processes and procedures.

▪ Participate and follow up on internal, external and customer centric quality audits and improvement projects.

SECONDARY RESPONSIBILITIES INCLUDE

▪ Assist in the investigation, root cause analysis and implementation of Corrective and Preventive action (CAPA).

▪ Performs all other duties as assigned

REQUIREMENTS

▪ AA/AS (BA/BS preferred) degree in a technical field of study, i.e. Engineering, or equivalent relevant work experience.

▪ 3 - 5 years' experience in QA/QC for support of design transfer, manufacturing and product release activities.

▪ 3 - 5 years' experience in a quality or engineering role in a manufacturing environment; medical device/Defense industry experience preferred. Precision Optics, image processing experience is also a plus.

▪ Quality experience within an industry recognized Quality Management System such as ISO9001, ISO13485, IATF 16949, AS9001.

▪ Must be able to understand and use; inspection tools (calipers, micrometers, drop and dial indicators, etc.) to measure physical dimensions from engineering drawings and specification requirements.

▪ Possesses knowledge and the application of; quality tools and methods for quality control and improvement projects. This includes hand-on experience with verification and validation methods (i.e. Gage

R & R, IQ/OQ/PQ

).

▪ Must be a team player who is willing to work long hours (if needed) and be flexible to support other departments.

▪ Keen attention to compliance and details. Able to understand directions and learn quickly.

▪ Excellent communication skills, both written and verbal. Interacts well with others throughout the organization.

▪ Computer proficiency; including using Microsoft WORD and

EXCEL. ERP

(SAP) experience helpful.

▪ U.S. Citizenship is required, due to government contract requirements. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

PHYSICAL REQUIREMENTS

The physical requirements 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 occasionally required to stand; walk; sit; use of hands or fingers to handle, or feel objects, tools or controls and keyboarding; reach with hands and arms; climb stairs; balance; stoop, kneel, crouch or crawl; talk and hear.

The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.