Quality Assurance Engineer Matrix Recruitment are currently recruiting for a Quality Assurance Engineerfor our client based in County Roscommon who specialises in the Medical Device industry.
Our client is a global leader in the manufacture of single-use medical devices, offering innovative solutions that improve patient care.
With state-of-the-art facilities and a commitment to quality and precision, they partner with leading healthcare companies to design and produce customised medical products.
With new opportunities on the horizon and significant advancement in projects and capabilities they are now looking to expand their team.
The Quality Assurance Engineer, reporting directly into the Quality Engineering Manager will be responsible forproviding quality support to optimise production performance by addressing quality issues, identifying root causes, and implementing corrective and preventive actions.
This is a permanent, Monday Friday position.
Quality Assurance Engineer Responsibilities: Adhere to company policies, procedures, and Quality/Environmental Management Systems, ensuring compliance with GMP and ISO standards.
Lead and support quality engineering activities for new and existing products, including inspection plans, process validations, and risk management.
Investigate and resolve quality issues using root cause analysis, CAPA implementation, and data-driven methodologies to enhance product and process quality.
Oversee non-conforming materials, customer complaints, and audits while maintaining accurate quality records and documentation.
Collaborate with cross-functional teams to support production, drive continuous improvement initiatives, and achieve key business deliverables.
Train and mentor junior quality engineers, fostering professional growth and adherence to quality standards across product lines.
Represent quality interests during audits, customer reviews, and project teams, ensuring the client and customer requirements are met consistently.
Quality Assurance Engineer Requirements: Degree (Level 8 or equivalent) in Quality Assurance or related field.
Minimum 3 years' experience in Quality Engineering, ideally in medical device manufacturing.
Strong knowledge of ISO 13485, ISO 14971, and QSR 21 CFR Part 820.
Proficiency in statistical analysis techniques, Microsoft Office, and ideally Syspro, Minitab, and Lotus Notes.
Excellent interpersonal and communication skills with the ability to influence cross- functional teams and manage customer requirements.
Proven ability to plan, prioritise, and drive projects to completion, with project management training considered an advantage.
Apply for this job now by sending in a Word version of your CV or reach out to Emma OConnor onor email By applying, you are giving consent for Matrix Recruitment to contact you about this job.
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Skills: quality engineer Quality Assurance minitab medical device industry