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QLTY & RELIABILITY TECHNICIAN III

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 also 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/

 

Job Overview

The Quality Operations Technician is a member of the Operations Quality group. They will work as part of a team to maintain high quality/performance standards on all Creganna Medical products. Reporting to the Area Operations Senior Quality Engineer, the position will be challenging and will require an ability to participate in a cross-functional team and work on own initiative and with minimum supervision.

Job Responsibilities


• Working with the Manufacturing teams promote the achievement of the Health and safety goals.
• Deliver on all KPIs that help the business achieve its goal.
• Performing batch review and release of product.  Working with manufacturing lines to ensure timely release of product to the customer.
• Implement corrective action on issues as they arise.
• Disposition non-conformances’, conduct & determine root cause analysis including corrective actions.
• Conduct area practice v’s procedure/Good Documentation Practice audits and follow up on findings to ensure satisfactory closure.
• Follow up on Corrective Actions for in-process and customer complaint issues.
• In-process sampling and testing and subsequent report writing.
• Conduct First Article Inspections on product as required.
• Processing procedure changes.
• Support all QA related documentation activities (i.e. Raise Change plans, write procedures etc)
• Review of sterilisation documentation and the release of sterilised product for shipping.
• Support functional area validation activities.
• Support Fault Analysis and Scrap Reduction activities.
• Participate/drive quality improvement projects/activities.
• Participate in preparing & on-going maintenance of FMEAs and Control Plans. Reporting function Quality metrics.
• Support NPI/manufacturing Operations area projects and initiatives e,g, Kaizen, yield improvement, cost reduction etc.
• Other tasks as directed by the functional area Quality Engineer in line with company goals and objectives. 
• Provide support for internal, customer and external audits to ISO and FDA requirements.
• Train operators on work instruction and procedural updates.

What your background should look like:

The Quality Operations Technician is a member of the Operations Quality group. They will work as part of a team to maintain high quality/performance standards on all Creganna Medical products. Reporting to the Area Operations Senior Quality Engineer, the position will be challenging and will require an ability to participate in a cross-functional team and work on own initiative and with minimum supervision.

Qualifications

• Level 8 degree in Science / Engineering / Quality Management or related fields essential is a minimum requirement. 
• Minimum of 1 years’ industry experience in a medical device manufacturing environment.


Key Requirements

• A problem-solving qualification (either Green or Yellow belt) preferred. 
• Clear understanding of medical device quality systems and requirements.
• Experience in product inspection techniques.
• Knowledge of root cause analytical and problem-solving skills.
• Knowledge of FDA and ISO Quality systems for Medical device companies desirable.
• Demonstrated excellent organizational skills and ability to work on own initiative essential.
• Excellent written and verbal communication skills essential.
• Computer literate, MS Word, Excel, PowerPoint.

Competencies

Values: Integrity, Accountability,Teamwork, Innovation
Location: 

GALWAY, G, IE, H91 VN2T

City:  GALWAY
State:  G
Country/Region:  IE
Travel:  None
Requisition ID:  78239
Alternative Locations: 
Function:  Engineering & Technology


Job Segment: Technician, Engineer, Maintenance, Quality Manager, Technology, Engineering, Manufacturing, Quality

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