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QLTY & RELIABILITY ENGINEER I

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


TE Connectivity (NYSE: TEL) is a $12 billion global technology leader. 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. In recent years the company has developed from a component manufacturer to offer specialization 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/
 

 

The Operations Quality Engineer is a member of the Operations Quality group. S/he is, responsible for Operations 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 within a collaborative environment, pursuing continuous improvement and ensuring compliance to the Creganna Medical Quality System. The focus of the role is to supply high quality medical devices and components to deliver an Extraordinary Customer Experience.
 

Responsibilities

•    The quality engineer will perform an active role in further development and continuous improvement of the quality management system.
•    The quality engineer will perform an active role in quality planning and new product introduction from a quality perspective.
•    Establish and maintain risk management principles and methods throughout the product realisation process in compliance with the company’s Quality Management system and ISO14971.
•    Maintain relevant documentation to comply with quality standards and customer requirements.
•    Offer quality guidance to a team of Quality Technicians in support of the day-to-day manufacturing operations. 
•    Develop strong links with customer organization’s and other project stakeholders.
•    Quality review of responsible area validation documentation.
•    Investigation of root cause and implementation of effective corrective actions to prevent re-occurrence of compliance issues.
•    Overall responsibility for production GMP standards and compliance.
•    Establishing inspection standards, sampling plans and test methods.
•    Preparing and updating Operations procedures and associated documentation.
•    Supporting customer audits and surveillance / accreditation audits.

 

What your background should look like:

Qualifications 

•    Level 8 degree in Quality or Degree in Science / Engineering.
•    Experience within a similar role as quality engineer.
•    1 - 3 years' industry experience in a medical device-manufacturing or pharmaceutical environment

 

 

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:  Less than 10%
Requisition ID:  75942
Alternative Locations: 
Function:  Engineering & Technology


Job Segment: Manufacturing Engineer, Engineer, Quality Manager, Risk Management, Engineering, Quality, Finance

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