Quality Technician

Uniting Holding; Galway; On-site; EUR 42,000 - 62,000; Full time

Job summary

Uniting Holding is seeking a Quality Technician to actively contribute to the evolution of the Quality Management System and drive continuous improvement across manufacturing and design engineering teams. You will support GMP standards, risk management, and customer audits while ensuring compliance with ISO13485 and related documentation.

You will work with engineers to deliver projects, lead corrective actions, and help maintain robust testing, validation activities, and production processes in

Qualifications

• A minimum of a certificate in a Quality/Science or related discipline preferred.
• Experience within a GMP regulated environmental as Quality technician.
• 3+ years industry experience in an ISO regulated environment advantageous
• Hands-on experience with Catheter products is an advantage.
• Excellent written and oral communication skills essential.
• Strong organizational and communication skills.
• Team player.

Responsibilities

• The Quality technician will perform an active role in further development and continuous improvement of the Quality Management system.
• Identifying any potential trends during failure analysis and initiating improvement initiatives relating to Cleanroom Environmental Monitoring.
• Lead corrective action activities related to manufacturing processes and systems and the NC/CAPA system.
• Offer quality guidance to a team of Product builders and Design Engineering teams in support of the day-to-day manufacturing operations.
• Responsibility for production GMP standards and compliance.
• Establish inspection standards and test methods including Validation activities.
• Prepare and update Operations procedures and associated documentation.
• Support customer audits and surveillance/accreditation audits.
• Conduct audits of the Manufacturing Operation and the Quality System ensuring compliance with ISO13485.
• Establish and maintain risk management principles and methods throughout the product
• Maintain relevant documentation to comply with quality standards and customer requirements.
• Support Operations area projects and initiatives i.e. Kaizen, data analysis, problem-solving tools, etc.
• Work closely with assigned engineers and project manager to deliver projects successfully. Manage own elements of projects and prototypes as requested.
• Deliver customer expectations, customer is our priority.Work with the ICÄ Medical Devices team to deliver for our customers.
• Systems – implement procedures, training and workflows per our quality systems.
• Process – support development and installation of process capable of meeting design specification and process that are capable of manufacturing customer product efficiently.
• Operate in a team environment, operate well with all members of our team, contribute positively to our team dynamic and business goals.
• Be flexible in support of projects and business goals and priorities.
• Operate in safe, efficient and clean manner. Always be considerate of follow team members and our customers.
• Seek opportunities for improvement for self and for the team and for the business.
• Know our business systems and processes, know our quality and design control systems.
• Developyourcommunication skills.
• Learn about our business and develop your experience and knowledge as you look to drive our business and your career forward.

Skills

Quality

Education

Certificate in Quality/Science or related discipline

Job description

Roles & Responsibilities:

Quality

• The Quality technician will perform an active role in further development and continuous improvement of the Quality Management system.


• Identifying any potential trends during failure analysis and initiating improvement initiatives relating to Cleanroom Environmental Monitoring.


• Lead corrective action activities related to manufacturing processes and systems and the NC/CAPA system.


• Offer quality guidance to a team of Product builders and Design Engineering teams in support of the day-to-day manufacturing operations.


• Responsibility for production GMP standards and compliance.


• Establish inspection standards and test methods including Validation activities.


• Prepare and update Operations procedures and associated documentation.


• Support customer audits and surveillance/accreditation audits.


• Conduct audits of the Manufacturing Operation and the Quality System ensuring compliance with ISO13485.


• Establish and maintain risk management principles and methods throughout the product


• Maintain relevant documentation to comply with quality standards and customer requirements.


• Support Operations area projects and initiatives i.e. Kaizen, data analysis, problem-solving tools, etc.

Customer First

• Work closely with assigned engineers and project manager to deliver projects successfully. Manage own elements of projects and prototypes as requested.


• Deliver customer expectations, customer is our priority.Work with the IC\u00c4 Medical Devices team to deliver for our customers.

Execute projects

• Systems – implement procedures, training and workflows per our quality systems.


• Process – support development and installation of process capable of meeting design specification and process that are capable of manufacturing customer product efficiently.

Team

• Operate in a team environment, operate well with all members of our team, contribute positively to our team dynamic and business goals.


• Be flexible in support of projects and business goals and priorities.


• Operate in safe, efficient and clean manner. Always be considerate of follow team members and our customers.


• Seek opportunities for improvement for self and for the team and for the business.

Self

• Know our business systems and processes, know our quality and design control systems.


• Developyourcommunication skills.


• Learn about our business and develop your experience and knowledge as you look to drive our business and your career forward.

Requirements (Education, Experience, Skills, Other)

• A minimum of a certificate in a Quality/Science or related discipline preferred


• Experience within a GMP regulated environmental as Quality technician.


• 3+ years industry experience in an ISO regulated environment advantageous


• Hands-on experience with Catheter products is an advantage.


• Excellent written and oral communication skills essential.


• Strong organizational and communication skills.


• Team player.