Role: Senior Quality Engineer (Operations)
Location: Neurent Medical Ltd., Galway
Department: Quality Assurance
Reporting: Quality Manager
DUTIES AND RESPONSIBILITIES:
* Support and mentor Quality engineers and technicians. Assign tasks, coordinate and provide instruction and feedback as required.
* Champion continuous improvement through CAPA system, analyzing key performance indicators etc.
* Lead quality-focused projects ensuring timely completion of project milestones.
* Ensure GMP standards and compliance in the assigned area.
* Work collaboratively with Operations, Supply Chain and other business functions to ensure quality performance of product and processes.
* Participate / lead Risk Analysis initiatives e.g. FMEA.
* Review/Approve Validation protocols, reports (IQ, OQ, PQ) and engineering changes.
* Develop and maintain documentation in compliance with FDA& ISO requirements.
* Collate, trend and report on Quality KPI’s.
* Perform internal and external audits to ISO and FDA requirements.
* Support Notified Body / Regulatory Agency / Customer Audits.
* Support the environmental monitoring process and activities associated with sterilization.
* Actively participate in management review, compliance meetings and other key review meetings.
* Act as the QA representative on Design Projects supporting new product introductions, qualification of new suppliers, development and approval of new product documentation.
* Supplier Management & Qualification: Maintain supplier records and systems, manage Approved Supplier List (ASL) activities, qualify new suppliers through agreements, assessments, audits, and onboarding to the Approved Vendor List (AVL).
* Coordinate supplier change requests and qualification plans, monitor supplier performance through scorecards and reviews, and conduct audits to drive corrective actions and ensure compliance.
* Undertake additional tasks as directed by the Quality Manager in line with company goals, and act as delegate for Quality Manager when required.
EDUCATION/EXPERIENCE:
* Level 8 Degree in Science / Engineering, Quality Engineering or similar qualification.
* Minimum 5 years’ experience in a relevant role in the medical device industry.
* Clear understanding of medical device quality systems and requirements, including measurement techniques, would be a distinct advantage.
* Experience in root cause analytical and problem-solving skills.
* Experience of FDA and ISO Quality systems (e.g. ISO13485, FDA QSR 21CFR Part 820) for medical device companies desirable.
* Significant test method and process validation experience.
* Demonstrated excellent organizational skills and ability to work on own initiative essential.
* Excellent written and verbal communication skills.
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