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Job Specification: Quality Engineer

Location: Mullingar, Co Westmeath
Job Type: Full-time

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Job Overview

Our client is seeking a dedicated Quality Engineer to join our team, playing a vital role in championing and rolling out strategic initiatives that align with our quality system requirements, specifically ISO 13485 and ISO 11607. This position will collaborate closely with our site team and support our Operations, Engineering, and R&D Teams, ensuring compliance and promoting a culture of quality across the organisation.

Key Responsibilities

• Quality Improvement Programs: Lead quality improvement initiatives using recognized problem-solving and project management techniques to enhance overall product quality and operational efficiency.

• Customer Interface: Maintain ongoing communication with customers to ensure all quality requirements are met, fostering strong relationships and understanding of customer needs.

• Document Management: Manage customer-related documents within the quality system, ensuring accurate and timely documentation that meets customer and regulatory requirements.

• Quality Documentation: Draft and approve quality documentation, including procedures, protocols, and reports, to ensure compliance with customer specifications and industry standards.

• Data Trending and Tracking: Analyse and trend quality data to identify areas for improvement and support data-driven decision-making across the business.

• Incoming Control Requirements: Adhere to incoming control requirements and support the Supplier Corrective Action Request (SCAR) process as necessary to address quality concerns.

• Quality Projects: Manage and oversee quality projects aimed at continuous improvement, ensuring alignment with organizational goals and objectives.

• Cross-Department Collaboration: Interface daily with other departments to promote quality awareness and integrate quality initiatives throughout the organisation.

• Batch Paperwork Review: Conduct thorough reviews of batch paperwork, making final decisions on product release for shipment, ensuring compliance with quality standards and regulations.

Qualifications

• Third Level qualification in Engineering/ Quality/ Science

• A working knowledge of quality systems such as ISO 13485 is essential

• An in-depth knowledge of Validations and change control management in a medical Device environment

• A working knowledge of Statistics, SPS, and ideally the use of Minitab.

• Auditing experience to the requirements of ISO 13485/ EU GMP/ 21 CRF Part 820

• Proven experience in leading quality improvement initiatives and managing projects.

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Additional Information

• All employees are expected to contribute to the maintenance of ISO 13485 standards within their roles.

• This position may require occasional travel to support site operations or customer engagements.

• Excellent communication and interpersonal skills, with the ability to effectively collaborate across departments and with external stakeholders.

• Proficient in quality management tools and methodologies, including statistical analysis and problem-solving techniques.

• Detail-oriented with strong organizational skills and the ability to manage multiple priorities.

Relevant Experience

•  2 Years experience in a Pharmaceutical/ Medical Device Environment

•  2 Years working knowledge of ISO 13485

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