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Associate Quality Engineer

TE Connectivity (NYSE: TEL) is a $14 billion global technology leader. Our connectivity and sensor solutions are essential in today’s increasingly connected world. We collaborate with engineers to transform their concepts into creations – redefining what’s possible using intelligent, efficient and high-performing TE products and solutions proven in harsh environments. Our 72,000 people, including over 7,000 engineers, partner with customers in over 150 countries across a wide range of industries. We believe EVERY CONNECTION COUNTS – www.TE.com.   

 

Creganna Medical is ranked among the top 10 global companies in the medical device outsourcing industry. The company specializes in the design and manufacture of minimally invasive delivery and access devices for a range of therapies. Serving over 400 companies across 30 countries, Creganna Medical’s customers include the world’s leading medical device and life science companies. Headquartered in Galway, Ireland, Creganna Medical has a global operational footprint with design and manufacturing facilities spanning the U.S., South America, Europe and Asia.  http://www.creganna.com/

 

 

 

 Job Title: Associate Quality Engineer

 

The Associate Quality Engineer is a member of the Quality group.

S/he is, responsible for  Quality within their prescribed area of functional responsibility.

S/he 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 moderate supervision, pursue continuous improvement and ensure compliance to the Creganna Medical Quality System

 

 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.
  • Support customer complaint, CAPA and NCR investigation activity.
  • 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 graduate quality engineer will perform a support role in quality planning and new product introduction from a quality perspective.
  • Have a working knowledge of ISO/FDA/MDD and other Product Development related regulatory requirements.
  • Maintain relevant documentation to comply with quality standards and customer requirements.
  • Where required provide support to customer organisation’s and other project stakeholders.
  • Support validation activity including review of relevant documentation.
  • Support the development and continuous improvement of the quality management system.
  • Support Operations area projects and initiatives i.e. Kaizen, CFPS, Opportunity for defect analysis, etc.
  • Support the preparation of and release of product pre and post sterilization.
  • Other duties as assigned from time to time.
     
    Qualifications
  • Level 8 degree in Quality or Degree in Science / Engineering.
  • Experience within a similar role as quality technician / engineer.
  • 2+yrs industry experience in a medical device-manufacturing or pharmaceutical environment.
     
     
    Job Requirements
  • Working knowledge of FDA and ISO 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.
     
     
     
Job Overview
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.
Responsibilities & Qualifications
Competencies
Values: Integrity, Accountability,Teamwork, Innovation
Location: 

Galway, G, IE, H91

Travel:  None
Requisition ID:  49037
Alternative Locations: 


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

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