SENIOR QUALITY ENGINEER (OPERATIONS)

AMA Consulting Group LLC; Galway; On-site; EUR 60,000 - 80,000; Full time

Job summary

A medical device company in Galway is looking for a Senior Quality Engineer to lead quality efforts, mentor staff, and ensure compliance with FDA and ISO standards. The ideal candidate has extensive experience in the medical device industry, a Level 8 degree, and strong analytical and problem-solving skills. This role involves supporting the Quality Manager and driving continuous improvement initiatives.

Qualifications

• Minimum 5 years’ experience in a relevant role in the medical device industry.
• Clear understanding of medical device quality systems and requirements.
• Significant test method and process validation experience.

Responsibilities

• Support and mentor Quality engineers and technicians.
• Champion continuous improvement through CAPA system.
• Lead quality-focused projects ensuring timely completion.
• Ensure GMP standards and compliance in assigned area.
• Participate / lead Risk Analysis initiatives.

Skills

Problem-solving skills

Organizational skills

Communication skills (written and verbal)

Root cause analysis

Experience with FDA and ISO Quality systems

Knowledge of quality engineering

Education

Level 8 Degree in Science / Engineering or Quality Engineering

Job description

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.