Position - Quality Engineer*

Exempt Position - Salary is commensurate with experience

 *This description is intended only to provide information about the general nature of the job and is not an all-inclusive list of job duties or requirements.

The duties of this job are executed in a climate-controlled environment with few temperataure or humidity extremes.

General:

Due to the continued expansion of our operations we currently have an opening for an additional Quality Engineer.     

Summary of Duties:

1. The Quality Engineer provides support to Manufacturing, Engineering, and customers through reporting and analysis of data, development of Quality Planning documentation, and execution of the Quality Management System.
2. Works to complete First Article Inspection Reports, Production Part Approval Process documents, and customer prescribed qualification requirements in prescribed formats including written narrative, as necessary.
3. Reviews customer drawings, specifications, and supporting documentation for quality requirements and assesses appropriate means of meeting customer expectations through all phases of product/process development, from quoting to production and on-going support.
4. Coordinates the creation and maintenance of FMEA’s, Control Plans, and other Product Quality Planning documents with a cross functional team.
5. Inspects and tests products at various stages of the production process using a variety of measuring and testing equipment.
6. Compiles and evaluates statistical data to determine and maintain quality of products and processes.
7. Provides assistance to Production employees regarding quality/measurement issues.
8. Plans measurement techniques and systems to support the accurate and timely gathering and evaluation of data.  Sets up, conducts and analyzes GR & R studies.
9. Communicates with suppliers regarding material complaints, material certificates, and corrective actions, etc.
10. Trains other employee regarding new and existing in-process inspection techniques.
11. Reports quality problems to the Quality Manager.
12. Updates and Maintain appropriate quality records.

Requirements:

Applicants must have a strong background in statistics/SPC, metrology, measurement techniques and processes. Prior quality knowledge and experience in medical parts manufacturing is preferred (ISO 13485, FDA Title 21). Experience or training in the use of testing and measuring equipment such as microscopes, visual systems, digital indicators and micrometers is necessary. A Bachelor’s degree or its equivalent and at least five years experience in Quality in a manufacturing setting is required. ASQ CQT/CQE certification a plus.