Position:
Business Project Manager – QA (Regulatory & Digital Transformation)
Location:
Athenry, Ireland and Hybrid
Experience:
8+ years (with strong QA/Regulatory project management background)
Domain:
Medical Device / Life Sciences / Regulated Manufacturing
Job Summary:
We are seeking a
Business Project Manager (QA – Regulatory)
to lead initiatives focused on enhancing Quality Management Systems (QMS) and driving digital transformation within regulated manufacturing environments. The ideal candidate will have strong experience in Quality Assurance, regulatory compliance (FDA, ISO 13485, EU MDR), and digital systems integration (MES, ERP, eQMS).
Key Responsibilities:
Quality & Regulatory Management
* Maintain and continuously improve the
Quality Management System (QMS)
in alignment with
ISO 13485
,
FDA regulations
, and other global standards.
* Ensure compliance with applicable
regulatory requirements
(FDA, EU MDR, ISO, 21 CFR Part 11).
* Support preparation for and participation in
internal and external audits
(FDA, Notified Bodies).
* Oversee documentation and management of
CAPAs, SCARs, deviations, and non-conformances
.
Digital Transformation & System Integration
* Integrate
quality controls
into automated, data-driven
manufacturing and digital workflows
.
* Collaborate with IT, Manufacturing, and QA teams to embed quality assurance into
MES (Manufacturing Execution Systems)
and
ERP systems
.
* Monitor and validate
data integrity
across digital platforms used in production and quality control.
* Lead or support
IQ/OQ/PQ validation activities
for new digital equipment and software systems.
* Review and approve
validation protocols, change controls, and technical documentation
.
Data, Analytics & Compliance
* Ensure
audit readiness
and compliance of digital systems and electronic records.
* Conduct
periodic trending analysis
of quality metrics and digital system performance.
* Support
predictive analytics and AI-based quality monitoring
initiatives.
* Provide guidance on
data governance, cybersecurity, and digital traceability
.
Training & Collaboration
* Train cross-functional teams on
QMS procedures
,
regulatory requirements
, and use of
digital QA tools
.
* Collaborate with engineering, manufacturing, and IT to ensure compliance and quality integration in all digital initiatives.
Preferred Experience & Skills:
* Proven experience in
Quality Assurance or Project Management
within
regulated industries
(medical device, life sciences, pharma, or manufacturing).
* Strong understanding of
ISO 13485, FDA QSR, EU MDR
, and
21 CFR Part 11
compliance.
* Experience managing
routers/Bill of Materials (BOMs)
and digital manufacturing transitions.
* Hands-on experience with
electronic DHR/DHR management
and presenting during audits.
* Knowledge of
software validation
,
electronic records compliance
, and
digital QMS systems
.
* Experience leading
cross-functional digital transformation projects
in a regulated setting.
* Excellent communication, stakeholder management, and documentation skills.
Education & Certification:
* Bachelor's or Master's degree in Engineering, Life Sciences, Quality, or related field.
* PMP, Six Sigma, or Quality Management certifications (CQE, CQA) preferred