Quality Engineer

Description

The Quality Engineer assists in the design and implementation of policies and procedures for testing and evaluating the precision and accuracy of products and/or equipment. The Quality Engineer will be expected to provide support to operations, interact with customers and provide support for Engineering, Quality Systems and Process engineering. 

Key Result Accountabilities

• Perform validations of new equipment/processes in the laboratory and production areas.
• Assist with corrective actions and root cause analyses.
• Performs process improvement projects both in the laboratory and production areas.
• Interacts with members of the manufacturing, quality, and IT team as well as other leadership in the company.
• Assists with qualification requirement of new customers.
• Collects data as needed, analysis of data and tracks/ensures trial/qualification orders are processed and documented properly.
• Perform internal audits for both quality and environmental and assist in third party and customer audits.
• Maintains internal specifications and assists with review and revision of other quality documents.
• Assist with reference material production.
• Plans and performs measurements to support production of new RM’s.
• Assist laboratory personnel and quality manager in data creation.
• Become competent with analyzers and as needed, assist with analyzer calibrations/ improvements.
• Interface with raw material suppliers.
• Assist with implementation of corporate quality initiatives and training.
• Member of the internal auditing team.
• Attain Green Belt training.
• All other job duties as assigned.

Requirements

• Bachelors degree in Engineering or related industrial, scientific, or business field required.
• 2-5 years’ experience in a quality role within a regulated industry, with increasing responsibility preferred.
• Experience with FDA, ISO 13485, AS9100, and ISO 9001, ISO 14001, Nadcap accreditations is a plus.
• Must be adept in use of computer software for the analysis of data, preferably Microsoft Excel and statistical packages.
• Quality Engineering certification (CQE) preferred or equivalent body of knowledge in areas which include but are not limited to Statistics, SPC, Geometric Dimensioning & Tolerancing; Sampling, Design of Experiments, etc. Ability to analyze, understand and effectively communicate this technical material. Experience with Lean Manufacturing and Six Sigma is a plus.
• Ability to organize and judge priorities in a dynamic, fast-paced environment and work independently with minimal supervision.
• Must possess excellent verbal & written communication skills, which include but are not limited to presentation, organizational and management skills.

Qualifications

Behaviors Preferred

• Team Player - Works well as a member of a group
• Detail Oriented - Capable of carrying out a given task with all details necessary to get the task done well
• Dedicated - Devoted to a task or purpose with loyalty or integrity

Education Required

Bachelors or better in Engineering or related field.

Experience Preferred

2-5 years’ experience in a quality role within a regulated industry, with increasing responsibility preferred.