Overview
ROLE: Senior Quality Engineer (Operations)
LOCATION: Galway
DEPARTMENT: Quality Assurance
REPORTING TO: Quality Manager
ROLE OVERVIEW:
Seeking a dedicated and detail-oriented Senior Quality Engineer to join an Operations team. The successful candidate will ensure the quality and compliance of manufacturing processes, contributing to the delivery of high-quality medical devices.
Responsibilities
* Mentor and support Quality engineers and technicians, assigning tasks and providing guidance and feedback.
* Drive continuous improvement through CAPA systems, KPI analysis, and quality-focused initiatives.
* Lead quality projects, ensuring timely completion of milestones.
* Ensure GMP compliance in assigned areas and collaborate with Operations, Supply Chain, and other teams to maintain product and process quality.
* Participate in and lead Risk Analysis initiatives (e.g., FMEA).
* Review and approve validation protocols and reports (IQ, OQ, PQ) and engineering changes.
* Maintain documentation in compliance with FDA and ISO requirements.
* Collate, trend, and report on Quality KPIs.
* Conduct internal and external audits to ISO and FDA standards, supporting regulatory and customer audits.
* Support environmental monitoring and sterilization activities.
* Act as QA representative on design projects, new product introductions, supplier qualifications, and product documentation approvals.
* Manage supplier relationships and qualification processes, including audits, performance monitoring, and corrective actions.
* Undertake additional tasks as directed by the Quality Manager and act as delegate when required.
Qualifications
* Education: Level 8 Degree in Science, Engineering, Quality Engineering, or a related field.
* Minimum 5 years’ relevant experience in the medical device industry.
* Strong understanding of medical device quality systems and measurement techniques.
* Experience with CAPA and root cause analysis.
* Knowledge of FDA and ISO Quality systems (e.g., ISO 13485, FDA QSR 21CFR Part 820) desirable.
* Experience with test method and process validation.
* Excellent organizational, written, and verbal communication skills.
Contact
Email address: stem@hero.ie
Contact number: 0868395533
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