Overview
Senior Quality Engineer
— Location: Galway, Ireland
We are looking for an experienced
Senior Quality Engineer
to join our team in Galway.
This role is key to ensuring product and process quality for medical devices in compliance with global regulatory standards.
Responsibilities
Support
new product introductions (NPI)
and existing manufacturing operations.
Lead
non-conformance, CAPA
, and
complaint investigations
.
Ensure compliance with
ISO *****, FDA 21 CFR Part 820
, and
MDR
.
Collaborate with cross-functional teams on
design controls
,
risk management
, and
validation
.
Support internal and external audits and drive
continuous improvement
.
Manage
supplier quality
and mentor junior team members.
Qualifications
Degree in Engineering, Science, or related field.
5+ years' experience
in quality within a
medical device
or regulated industry.
Strong knowledge of
regulatory standards
, CAPA, and validation.
Experience with
Lean/Six Sigma
tools; CQE or Green Belt a plus.
Excellent problem-solving and communication skills.
#J-*****-Ljbffr