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Quality Engineer - NPD

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 $14 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 in 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 quality planning and new product introduction from a quality perspective.
•Maintain relevant documentation to comply with quality standards and customer requirements.
•Develop strong links with customer organization’s and other project stakeholders.
•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.
•Establishing and maintaining FMEA’s.
•Preparing and updating Operations procedures and associated documentation.
•Reporting area of responsibility metrics.
•Supporting customer audits and surveillance / accreditation audits.
•Conducting audits of the manufacturing operation ensuring compliance with the Quality Management system and ISO13485.
•Support Operations area projects and initiatives i.e. Kaizen, problem solving tools, etc.
•Other duties as assigned from time to time.

What your background should look like:

•2+ years industry experience in a medical device-manufacturing or pharmaceutical environment.
•Level 8 degree in Quality or Degree in Science / Engineering.


Key Requirements

•Experience within a similar role as quality engineer.
•Working knowledge of FDA/ISO/MDD Quality systems for Medical device companies.
•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:  79083
Alternative Locations: 
Function:  Engineering & Technology


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

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