Quality Engineer
We are seeking a motivated and detail-oriented Quality Engineer for a site-based position in Cork. This role is based on a large Medical Device manufacturing facility and is ideal for someone with early career experience in the medical device industry or a closely related regulated field. You’ll play a key role in supporting our quality systems, ensuring compliance with industry standards, and driving continuous improvement across operations and quality engineering functions.
Key Responsibilities:
* Assist in the development and review of process and equipment validation/qualification. Build proficiency in validation processes.
* Participate in root cause analysis, corrective and preventive actions (CAPAs), and risk management activities.
* Support manufacturing transfers to other plants/facilities, execution quality activities.
* Assist in internal and external audits and ensure timely closure of findings.
* Collaborate cross-functionally with operations, R&D, and regulatory teams to maintain product quality and compliance.
* Support validation activities, including IQ/OQ/PQ, and document control processes.
* Contribute to quality metrics tracking and reporting to drive continuous improvement.
Requirements:
* 6–24 months of experience in a Quality Engineering, Operations, or similar role within the medical device, pharmaceutical, biotech, or other regulated industry.
* Bachelor’s degree in Engineering, Life Sciences, or a related field.
* Working knowledge of quality principles, industry standards, and regulatory requirements.
* Strong problem-solving, communication, and organizational skills.
Preferred Qualifications:
* Hands-on experience with CAPA, non-conformance investigations, or change control processes.
* Exposure to validation, process improvement, or statistical analysis tools.
* Familiarity with QMS software and documentation systems.
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