(Only 24h Left) SENIOR QUALITY ENGINEER

19 hours ago

Galway, Ireland AMA Consulting Group LLC Full time

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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