Senior Quality Engineer (Operations & Compliance Lead)
Join an innovative, growing Medical Device company based in Galway, focused on pioneering solutions that are changing patient lives in the healthcare sector.
We operate a proactive Quality Assurance department that is integral to our Operations team and drives compliance and continuous improvement throughout our manufacturing and supplier are seeking a proactive and detail-oriented Senior Quality Engineer to act as a technical and quality champion for our Operations team.
This role is a key leadership position focused on managing and improving the QMS, leading complex quality projects, and ensuring robust supplier qualification.
If you have a passion for driving systemic improvement and want a pathway to management responsibility, this is the ideal next step.
Key Responsibilities
Continuous Improvement & CAPA:
Champion continuous improvement initiatives, driving the
CAPA system
and analyzing key Quality KPI's to reduce variation and improve performance.
Quality Leadership:
Support and
mentor junior Quality Engineers and Technicians
, assigning tasks, coordinating workload, and providing technical instruction and feedback.
Validation & Documentation:
Review and approve crucial documentation, including
Validation protocols and reports (IQ, OQ, PQ)
, and engineering changes.
Audits & Compliance:
Lead and participate in internal and external audits to
ISO ***** and FDA
requirements, and support Notified Body and Regulatory Agency inspections.
Supplier Qualification:
Lead
Supplier Management and Qualification
activities, including maintaining the Approved Supplier List (ASL), qualifying new vendors through audits and assessments, and monitoring supplier performance via scorecards.
Cross-Functional Support:
Act as the
Quality Assurance representative on Design Projects
supporting new product introductions, and ensure
GMP standards
are upheld across all areas (Operations and Supply Chain).
Risk Management:
Actively participate in and/or lead Risk Analysis initiatives (e.g.,
FMEA
) and root cause analysis investigations.
Candidate Profile
Education:
Level 8 Degree (or equivalent) in Science, Engineering, Quality Engineering, or a similar technical field.
Experience:
Minimum
5 years' relevant experience
within the Medical Device industry is essential.
QMS & Regulatory:
Clear understanding and practical experience with
FDA QSR (21CFR Part 820)
and
ISO *****
Quality Systems.
Core Technical Skills:
Significant experience with
test method and process validation
activities is a must.
Problem Solving:
Proven experience in
root cause analysis and CAPA
methodologies.
Organizational:
Excellent organizational skills and the ability to work effectively on own initiative are essential.
Advantageous:
Experience in
people management
or demonstrated mentorship experience is highly desirable.
Interested in leading high-impact Quality projects in Galway?
Apply in confidence today or contact James Cassidy for more details.
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