Quality Engineer

The Quality Engineer will provide the direct support for quality improvement, continued planning, coordinating, establishing, and directing the quality assurance program for medical/dental/forensic devices. This will be accomplished using an ISO Quality Management System. They will use highly refined communication skills to educate, inform, assist, and direct both internal and external organizations and customers using a consultative methodology.

 

Essential Responsibilities:

--Ensure customer satisfaction through quick follow up to problems, customer concerns, good root cause analysis and complete feedback.
--Track and monitor engineering changes and proposals.
--Coordinate special build events.
--Assist in ISO TS 16949 and 13485 maintenance.
--Thoroughly evaluate all customer returns and determine root causes.
--Publish Quality Alerts as required.
--Follow up to ensure that standard work instructions, control plan and process FMEA address all customer build concerns.
--Continuously review process to look for process improvement activities.
--Assure that quality documentation meets requirements set forth on control plan, part prints, TS16949 and 13485.
--Responsible for supplier and customer PPAPs.
--Provides training and guidance to other groups relative to quality, process control, data collection, and best practices

--Implements ongoing quality improvement processes working with interdepartmental teams

--Monitors and reports quality and compliance data on an on-going basis relative to product, components, customer and supplier quality

--Manages the development and implementation of customer required quality assurance plans or data

--Responds to customer required quality questions or surveys, customer and supplier satisfaction assessments, interviews, and meetings

 

Qualification Requirements:

Bachelor of Science degree in Engineering related field and understand mechanical and electronics related to medical devices

3-5 years experience in Quality Improvement Activities in an electronics manufacturing facility

Practical experience in Problem Solving Tools, Lean Manufacturing and Six Sigma Methodology

Working knowledge of ISO TS 16949 and 13485

Familiar with PPAP requirements

Excellent skills using MS Office tools (Excel, Word, Powerpoint, etc)

8D Report knowledge and experience

QMS experience