Senior Quality Engineer

The Quality Engineer acts as a key customer contact for all quality related issues within operations. They work collaboratively with the Certified Floor Auditor Level IIIs and the Quality Layout Technicians as well as members of the Production and Customer Service teams to ensure that all quality standards are being met. They formulate operating practices to address preventative action requirements in order to avoid nonconformance and ensure that end products meet and/or exceed customer specifications.

Duties and Responsibilities:

• Leads continuous improvement efforts within the manufacturing cell. Analyzes data to determine appropriate Root cause and corrective actions needed.
• Responsible for review and disposition of non-conforming product.
• Develops qualification protocols and control plans to meet all customer requirements while minimizing scrap and eliminating customer returns.
• Verifies that all appropriate instructions are in place to meet customer, FDA and/or other outside agencies requirements.
• Supports CFA Level III and Quality Layout Technicians by creating and explaining procedures and quality standards.

Qualifications:

MINIMUM QUALIFICATIONS:

• Degree in relevant field of study and 2+ years’ experience in quality engineering or A High School Diploma, GED and a minimum 5+ years manufacturing experience.
• Experience in Medical Device or FDA regulations.
• Ability to work with minimal supervision.
• Possess an attention for detail with a high degree of accuracy.
• Advanced computer experience/ proficiency.
• Ability to read and interpret documents such as safety rules, blue prints, operating and maintenance instructions, and SOP’s.
• Ability to add, subtract, multiply, and divide, using whole numbers, common fractions, and decimals.
• Must apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.
• Ability to multitask and problem solve involving several variables in working situations.
• Proficient in use of statistical tools and have a strong understanding of Statistical Process Control methodology to the quality assurance process.

PREFERRED QUALIFICATIONS

BS/BA degree in relevant field of study

Six-sigma experience green or black belt.

Competencies:

• Individuals should possess the following competencies to perform the job successfully.
• Communicates effectively, in oral and written communications.
• Translates company procedures and technical data into information that internal or external customers will understand.
• Implements and manages change by clarifying new processes and continuously providing communication to support change.
• Recognizes areas for improvement and takes actions to implement those improvements.
• Solves problems effectively by considering alternative solutions and possible consequences and takes into account other perspectives before making decisions.
• Attention to detail with thoroughness in accomplishing tasks. Monitors and checks work, plans and organizes time and resources efficiently.
• Builds strong relationships, works effectively and relates well with others including coworkers and those outside the organization. The employee exhibits a professional manner in dealing with others and works to maintain constructive working relationships.