Medical & Science jobs in Galway, County Galway

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 ICS 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.

• Develop your communication 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.