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Quality Technician - job post

ICS Medical Devices
3.1 out of 5 stars
Galway, County Galway
Full-time

Job details

Job type

  • Full-time

Location

Galway, County Galway

Full 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 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.

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