Quality Engineer
We are seeking a motivated quality engineer to join our multi-product manufacturing facility in Dublin. This role supports the Quality Manager in maintaining a robust Quality Management System (QMS) and ensuring compliance with corporate policies, ISO standards, and regulatory requirements.
Key Responsibilities:
* Develop, implement, and maintain the Quality Management System (QMS), including document control, change management, CAPA, and complaint handling.
* Perform internal audits and support external audits for regulatory and customer compliance.
* Oversee supplier quality management and conduct supplier audits as necessary.
* Support product realization activities, such as validation, process capability, and equipment qualification.
* Perform risk assessments and implement quality risk management strategies.
* Manage the testing, review, and disposition of production batches and raw materials.
* Collaborate with customers during audits and resolve quality issues through effective communication.
Qualifications and Skills:
* Bachelor's Degree in Engineering or Science.
* 3 years Experience in a regulated industry (e.g., pharma, biopharma, medical device) within a manufacturing environment.
* Previous roles in quality system development or implementation in manufacturing.
* Strong understanding of ISO standards, cGMP practices and lean manufacturing.
* Knowledge of sterile programs and sterility management is desirable.
* Proficient in Microsoft Office Suite and quality-related software.
* Strong analytical, communication, and problem-solving skills with a team-oriented mindset.
Estimated Salary: €60,000 - €80,000 per annum