Quality Assurance Engineer
We are currently recruiting for a Quality Assurance Engineer to join our client based in County Roscommon, specialising 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.
Job 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 client and customer requirements are met consistently.
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.