Staff Quality Engineer

Job Overview

The Staff Quality Engineer will focus on one of TE Connectivity - Medical value streams, working with manufacturing teams to sustain and improve manufacturing quality on Class II and III medical devices. You'll utilize your statistical strengths in SPC-implementation projects, increase efficiencies using continuous improvement methods, and interact with the customers frequently.

Responsibilities

• Performing an active role in further development and continuous improvement of the quality management system through identified initiatives, focusing on more mid-term/long-term projects as opposed to day-to-day tactical production line support.
  
• Investigation of root cause and following through on effective corrective actions to prevent re-occurrence for the customer and internal quality issues.
  
• Establishing inspection standards, plans, frequencies and test methods.
  
• Preparing and updating Operations procedures and associated documentation.
  
• Supporting customer and surveillance accreditation audits.
  
• The Staff Quality Engineer will perform an active role in quality planning and new product introduction from a quality perspective.
  
• Maintain relevant documentation to comply with quality standards and customer requirements.
  
• Quality review of responsible area validation documentation.
  
• Participates as a key member of new product development core teams, to help ensure that new product quality plans (validation plans, raw/component material specifications, etc.) and risk management files are appropriately established.
  
• Will assist and train associates in concepts of probability and statistics.
  
• Design and develop forms and instructions for recording, evaluating, and reporting quality data.
  
• Investigate and implement corrective and preventive actions (CAPAs) to meet business and compliance requirements.
  
• Assist with the development and maintenance of the company-wide validation programs.
  
• Reports verbally and in writing to the Director / Manager regarding the progress and results of projects.
  
• Participates with the Director / Manager in the preparation of divisional, departmental, and project goals.
  
• Assists the Director / Manager in presentations of technical nature when requested.
  
• Ensure that every product and service we supply conforms to FDA and Quality System Regulations as well as EN46001/ISO13485/MDD Standards.
  

What your background should look like:

• BS/BA degree with a scientific emphasis required
  
• Min. 8 years' experience as quality engineer
  
• Good working knowledge of ISO/FDA/MDD and other Product Development related regulatory requirements.
  
• ASQ Certified Quality Engineer preferred
  
• Six Sigma Green/Black belt preferred
  
• Quality experience in component and device manufacturing preferred.
  
• Excellent written and oral communication skills essential.
  

Competencies