​What you need to know

A leading medical device company that has a global reach and is at the forefront of developing new medical technologies are currently seeking an experienced Senior Quality Engineer for a 12-month contract in Galway City.

As a Senior Quality Engineer, you will provide quality engineering support, focusing on areas such as process validation, product development technology transfer, and continuous improvement projects. You will report directly to the Quality Manager and work collaboratively with various departments to ensure quality standards are upheld.

This is a 12-month contract. 

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Your new job

Key duties & responsibilities include:

• Provide Quality Engineering support, with a focus on process validation, to product development, technology transfer, improvement projects and/or core teams.

• As part of a cross-functional team, support the execution of process validation activities together with technology transfers from other locations.

• Provide quality focus and technical support for task teams.

• Support the characterization and risk assessment of manufacturing processes and associated equipment.

• Work within project teams to establish process controls that ensure the safety and efficacy of the product.

• Providing ongoing communication, information transfer and record-keeping in support of department and core-team objectives and metrics.

• Understand product construction, and features, and make decisions on product acceptance standards.

• Use and establish analysis techniques and other quality control tools to aid decision–making.

• Function effectively as a quality engineering team member and as part of a wider cross-functional team, developing strong relationships with other teams, at both the manufacturing and design sites.

• Participate in and initiate job-related training courses.

What are we looking for?

• Minimum of a Bachelor’s degree (Level 8 NFQ) in a relevant technical discipline, Science, Engineering etc.

• A minimum of 5 years’ experience in a medical device or related environment with direct experience in a QA environment (GMP regulated).

• A good working knowledge of process validation is essential.

• A good working knowledge of equipment validation and software validation is desirable.

• High level of interpersonal communication and organizational skills, along with the ability to positively influence project teams.

• Good working knowledge of statistical data analysis and quality improvement tools and techniques preferable.

• Strong technical writing skills.

• Ability to take initiative, organise and prioritise own work and proactively contribute to project-level strategies and planning.

• Effective time management skills.

• Able to analyse and chart data using MS Excel or Minitab

• Previous Quality Auditor experience is desirable, or certification is an advantage.

Interested in this role? 

Apply for this job now with a Word version of your CV.

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