(Only 24h Left) SENIOR QUALITY ENGINEER
4 weeks ago
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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