EPM Scientific
Senior Quality Engineer (Integration Programme)
Belfast
Posted about 17 hours ago
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Senior Quality Engineer (Integration Programme)
Location: Belfast, Northern Ireland (On-Site)
Contract Length: Up to 24 Months
Hours: Full-time (40 hours per week)
Start Date: ASAP
Responsibilities
- Assess the acquired site's quality system, engineering processes and manufacturing controls against standards and identify integration requirements.
- Perform gap assessments across procedures, validation activities, risk management processes, FMEAs and quality documentation.
- Develop and execute plans to harmonise local processes with Quality Management System.
- Support the integration and remediation of FMEAs, risk files, process documentation and manufacturing quality records.
- Execute process validation activities where required, including validation remediation and implementation of appropriate controls.
- Review production and process controls, working with manufacturing teams to ensure compliance and alignment with corporate requirements.
- Support first article inspections, process improvements and quality engineering activities across the site.
- Drive quality system improvements, corrective actions and integration workstreams throughout the acquisition programme.
- Work closely with cross-functional Quality, Engineering and Manufacturing stakeholders to deliver integration milestones.
- Operate as a hands-on project resource, supporting both strategic integration activities and day-to-day execution on the manufacturing floor.
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Requirements
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- 5-15 years' experience in medical devices or another highly regulated manufacturing environment.
- Strong background in Quality Engineering, Validation and risk management activities, including FMEAs and process controls.
- Hands-on experience executing process validations (IQ/OQ/PQ) and supporting remediation or integration projects.
- Engineering-led profile with exposure to QMS, CAPA, non-conformances and quality system improvements.
- Comfortable working autonomously on-site and collaborating with manufacturing, quality and engineering stakeholders.
- Previous experience within acquisitions, site integrations, quality transformations or manufacturing improvement programmes would be advantageous.
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Skills
Quality Engineering
Process Validation
Risk Management
FMEA
Quality Management System
IQ/OQ/PQ
CAPA
Gap Assessment
Manufacturing Controls
First Article Inspection
Site Integration
Non-conformances