Position: Product Manager + QA (Regulatory)
Location:
Athenry (Galway), Ireland
Position Type:
Contract
Are you passionate about driving quality and compliance in a digital manufacturing environment? We're looking for a
Product Manager + QA (Regulatory)
professional to support our transformation toward data-driven, automated, and compliant operations.
Key Responsibilities:
* Maintain and enhance the
Quality Management System (QMS)
in alignment with
ISO 13485
and
FDA regulations
.
* Ensure compliance with
FDA, EU MDR, and ISO
standards across all processes.
* Integrate quality assurance into
digital workflows
,
MES
, and
ERP systems
.
* Monitor and validate
data integrity
across digital platforms used in production and quality control.
* Lead or support
IQ/OQ/PQ
activities for new digital equipment and software systems.
* Review and approve
validation protocols
, technical documentation, and
change controls
.
* Manage documentation for
CAPAs, SCARs, and non-conformances
.
* Prepare for and participate in
FDA and Notified Body audits
.
* Conduct trending analyses of quality metrics and digital system performance.
* Provide training on regulatory requirements, QMS procedures, and digital tools.
* Offer guidance on
data governance
,
cybersecurity
, and
digital traceability
in regulated environments.
Preferred Skills & Experience:
* Proven experience in managing
routers/Bill of Materials (BOMs)
and manufacturing transitions to digital platforms.
* Hands-on experience with
DHR/eDHR management
via
MES systems
.
* Audit experience presenting on
electronic DHR
.
* Strong knowledge of
software validation
and
21 CFR Part 11
compliance.
* Familiarity with
predictive analytics and AI tools
for quality monitoring.
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