A leading medical device company with global operations who are experiencing strong growth is seeking an experienced and committed Senior Quality Engineer to join its team in Co Leitrim.

The company has an outstanding track record in designing, developing, and manufacturing cutting-edge medical device products that save and improve patients’ lives. The company is committed to delivering innovative products and prides itself on its industry-leading quality, lean manufacturing, and processing technologies.

As a Senior Quality Engineer, you will report directly to the Quality Manager on-site and work to ensure that the company’s quality systems are maintained to the highest of standards and that product quality and documentation processes are adhered to.

This is a permanent role with an excellent salary and benefits.

Your new job

Responsibilities & duties:

• Manage sterilisation processes for new product introductions (NPI) and maintenance of existing validated sterilisation cycles within the company’s site. 

• Participate in new product introductions programme to ensure that they are effectively introduced in accordance with the requirements of ISO 13845 and GMP.

• Participate and assist with other validations that impact the sterilisation processes, such as packaging validations.

• Participate in Customer Complaint investigation process and in routine failure investigation. 

• Participate in the Plant Corrective Action Programme.

• Participate in the Internal Quality Audit Programme.

• Work closely with the Head of Quality to determine the suitability of developing in-house sterilisation processes.

• Contribute to continuous improvement activities.

What are we looking for?

• Degree in Engineering, Manufacturing, Quality. Or another relevant discipline.

• Minimum of 5 years of experience in Quality/Validation in Medical Device/Pharma Environment

• Knowledge of sterilisation processes (EO and Irradiation) is essential.

• Possess excellent analytical and problem-solving skills with the ability to offer innovative solutions to challenges. 

• Strong organisation skills and the ability to prioritise tasks effectively and meet deadlines.

• Be able to handle multiple projects and prioritise your own work.

• Strong communication skills (oral and written).

• Enthusiastic and results orientated with good teamwork skills.

Apply for this job now by sending a Word version of your CV or get in touch with Oliver at oliver@matrixrecruitment.ie

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