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Quality Engineer - Operations

At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. 

Job Overview

The Quality Engineer - Operations is a member of the Quality Operations group.
The successful candidate will be responsible for Operations Quality within their prescribed area of functional responsibility. They will be working as part of a team to maintain high quality / performance standards on all Creganna Medical products.
This challenging position will require an ability to work with minimum supervision, pursue continuous improvement and ensure compliance to the Creganna Medical Quality System.

 

TE Connectivity’s Quality and Reliability Engineering Teams analyze the ability of product and production systems to comply with customer and contractual requirements through established reliability factors. They design, recommend revisions and install quality control systems, develop and document analytical methods for establishing reliability of products and their components and conduct analysis on relative reliability with regards to cost, structure, weight, maintainability, facility of production, and availability of materials and equipment. Out teams develop, implement and monitor company environmental safety programs and policies to ensure compliance with federal, state, and local environmental, health and safety regulations and recommend corrective actions if necessary. They are responsible for policies and practices to comply with applicable government regulations and industry requirements related to product environmental compliance, the implementation and management of technical and testing standards and specifications, quality control and reliability programs governing materials, product and processes, resulting in the optimization of material and labor, as well as failure analysis, root cause, corrective action and customer communication.

Job Responsibilities

  • Overall responsibility for production GMP standards and compliance.
  • Investigation of root cause and following through on effective corrective actions to prevent re-occurrence for customer and internal quality issues.
  • Establishing inspection standards, plans, frequencies and test methods.
  • Establishing and maintaining FMEA’s.
  • Preparing and updating Operations procedures and associated documentation.
  • Reporting area of responsibility metrics.
  • Supporting customer and surveillance accreditation audits.
  • The Quality Engineer will perform an active role in quality planning and new product introduction from a quality perspective.
  • Have a good working knowledge of ISO/FDA/MDD and other Product Development related regulatory requirements.
  • Maintain relevant documentation to comply with quality standards and customer requirements.
  • Develop strong links with customer organization’s and other project stakeholders.
  • Quality review of responsible area validation documentation.
  • Performing an active role in further development and continuous improvement of the quality management system.
  • Support Operations area projects and initiatives i.e. Kaizen, CFPS, etc.
  • Other duties as assigned from time to time.

What your background should look like:

Qualifications

  • Level 8 Quality / Science / Engineering degree.
  • Experience within a similar role as Quality Engineer.
  • 5+yrs industry experience in a medical device-manufacturing or pharmaceutical environment.

 

Key Requirements

  • Working knowledge of FDA/ISO/MDD quality systems for medical device companies.
  • New product introduction and manufacturing process transfer experience would be a distinct advantage.
  • Quality experience in component and device manufacturing desirable.
  • Excellent written and oral communication skills essential.
     

Competencies

Values: Integrity, Accountability,Teamwork, Innovation
Location: 

GALWAY, G, IE, H91 VN2T

City:  GALWAY
State:  G
Country/Region:  IE
Travel:  None
Requisition ID:  71962
Alternative Locations: 
Function:  Engineering & Technology


Job Segment: Operations Manager, Quality Engineer, Engineer, Engineering, Operations, Quality

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