Senior Quality Engineer (Integration Programme)

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.

Requirements

• 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.