Job Overview

TE Connectivity's Quality Control and Reliability Teams ensure product and / or product components comply with specifications and quality standards. They test and inspect products against performance and integrity criteria to ensure product quality and reliability, and to determine the suitability of product release.

Quality Analyst II, Document Controller works within the Document Control Team as the responsible party for developing and maintaining systems for document storage and retrieval, and trains other employees on efficient system usage. They work on systemic evaluation of documents submitted to ensure that standards of quality are being met in both manufacturing as well as design development. They are also responsible for document security and efficient document maintenance.

Responsibilities:

• Maintain documentation system (e.g., QP3, Intelex and transition into SmartSolve) according to site Document Control requirements;
  
• Documentation management including document registry, control, release, maintenance, withdraw and scrap of obsolete document etc.
  
• Review documents submitted by users for accuracy and facilitate updates prior to ECO initiation to ensure proper templates are used and writing in submissions is clear and concise to promote and maintain quality standards
  
• Review and update documents as needed
  
• Keep other personnel updated on new document versions
  
• Handle records and documents across various departments
  
• Create and revise templates for use by other personnel
  
• Control internal & external documents in order to meet customers & internal Document Control requirements.
  
• Manage quality records, such as DHF, DMRs, technical reports, validation documents and records, FAIR and ECN etc.
  
• Ensure only current controlled documents are available at point of use
  
• Serve on the Internal Audit Team to complete any internal audits assigned
  
• Promotes awareness of Document Control requirements throughout the organization
  
• Assists document owners and change initiators with changes as needed
  
• Identifies process gaps and ensures policies/procedures are revised for improvements to fulfil Document Control Requirements
  
• Facilitate retrieval of records during audits
  
• Create, analyze, and report on quality metrics for Document Control
  
• Other tasks assigned by Quality Manager as necessary to implement Company Objectives

What your background should look like:

Qualifications:

• 2-4 year degree, AS/BS with a scientific or engineering emphasis required
  
• GMP and ISO knowledge required, ISO 13485 preferred
  
• Minimum of ten (10) years’ work experience in a related regulated environment, medical device
  
• Minimum of three to five (3-5) years' experience as a Document Controller or quality system specialist in the medical device, diagnostic or pharmaceutical industry
  
• Use of and strong working knowledge in use of electronic Document Management System required
  
• Hands on skills in Office software required, e.g., Word, PowerPoint, Excel.
  
• Strong understanding of Change Control activities in a regulated industry; review of activities and implementation related to engineering change orders and notification process
  
• Proficient in typing and editing skills
  
• Lead Auditor, ISO 13485 or other ISO standard certification a plus
  
• Attention to detail required
  
• Ability to manage tight timelines and changing priorities
  
• Excellent problem-solving techniques
  
• Excellent communications skills
  
• Ability to work with many different levels of the organization for successful coordination and implementation of document and specification changes

Competencies