Medical Device Quality Assurance Specialist

7 days ago


Naas, Co Kildare, Ireland CPL Full time

Company Overview

CPL is a leading contract manufacturing partner to global heritage brands across the medical device and sterile injectable products sector. With a strong focus on quality and innovation, we are committed to delivering high-quality products that meet the stringent regulatory requirements of the industry.

Job Description

We are seeking an experienced Quality Engineer to join our team at our site in North Co. Kildare. As a key member of our Quality Operations team, you will play a critical role in ensuring the delivery of high-quality medical devices to our clients. Your primary responsibilities will include:

  • Supporting the ongoing development of our Quality Engineering function through the identification and introduction of new world-class techniques and technologies.
  • Liaising with Automated Production & Engineering to ensure that the goals, targets, and objectives of the group are continuously met.
  • Representing the company's expertise and support to all aspects of our operations on quality issues.
  • Investigating productivity issues, product, plant or material deviations, and liaising directly with external suppliers as well as all other stakeholders in the manufacturing process onsite.
  • SUPPORTING THE PRODUCTION LINE AREAS FOR QUALITY AND MATERIAL ISSUES AS REQUIRED.
  • Closely working with partners across the value chain for process, quality, and cost improvements projects.
  • Contributing to the development of the Quality Engineering function for the plant through the identification and introduction of new world-class techniques and technologies.
  • Liaising with Automated Production & Engineering to ensure that the goals, targets, and objectives of the group are continuously met.
  • Representing the company's expertise and support to all aspects of our operations on quality issues.
  • Work as part of the quality team in the overall support/service of the manufacturing operation, through the introduction of new technology/techniques, skill development, training, process optimisation and cost saving projects.
  • Provide specialist quality and technical engineering support to all departments.
  • E nsure the maintenance, management, and development of our Quality Management System.
  • Lead and participate in cross-functional teams & process improvement initiatives.
  • Further develop our Quality Lab resource in line with product qualification and inspection demands.
  • E nsure validation and qualification of all new and existing products, equipment, and processes.

Required Skills and Qualifications

To be successful in this role, you will require:

  • A minimum of 3 years' experience in Medical Device, Food, and/or Beverage production or pharmaceutical manufacturing product development, quality control, and/or cGMP compliance.
  • A BSc in Engineering, Quality Systems Management, or other related field of expertise.
  • Experience with ISO13485 would be a major advantage.

Benefits

We offer a competitive salary and benefits package, including:

  • An attractive salary package.
  • Ongoing training and development opportunities.
  • A dynamic and supportive work environment.
  • The opportunity to work on-site in North Co. Kildare.


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