Mechanical QAQC Inspection Engineer
Posted 1 day 6 hours ago by Fohntech Group
Permanent
Full Time
Other
Limerick, Ireland
Job Description
Limerick, Ireland Posted on 02/24/2026
We are seeking an experienced Mechanical QAQC Inspection Engineer with a robust background in Mechanical Engineering, and a proven track record in both the Pharmaceutical and Construction sectors. This is a unique cross-industry role requiring a deep understanding of GMP, GEP, and engineering best practices to oversee and enhance quality processes throughout the project lifecycle.
Key Responsibilities- Lead QA activities across pharma and construction projects, ensuring compliance with GMP, GEP, ISO standards, and other applicable regulations.
- Develop, implement, and maintain Quality Management Systems (QMS) to ensure adherence to project, client, and regulatory requirements.
- Oversee mechanical system installations (e.g., HVAC, piping, pressure vessels) with a focus on quality and compliance in both cleanroom and construction environments.
- Coordinate with multidisciplinary teams including engineering, validation, commissioning, construction, and operations to align quality standards.
- Perform supplier and contractor audits, review quality documentation, and ensure proper IQ/OQ/PQ protocols are followed (in pharma).
- Lead Non Conformance (NC) investigations, CAPAs, and root cause analysis for deviations in construction or pharma environments.
- Ensure all materials, equipment, and systems used in construction or manufacturing are installed and qualified to meet regulatory expectations.
- Participate in project planning, risk assessments, and quality reviews from design through handover phases.
- Serve as the primary quality interface with regulatory bodies and client auditors.
- Bachelor's degree (or higher) in Mechanical Engineering.
- QA experience, with at least 3 5 years in Pharma (GMP environment) and 3+ years in Construction/Infrastructure.
- Solid understanding of mechanical systems within GMP manufacturing and industrial construction.
- Hands on experience with validation, commissioning, and qualification processes.
- Strong familiarity with regulatory standards such as FDA, EMA, MHRA, and ISO 9001.
- Experience implementing or working with QMS platforms (e.g., TrackWise, MasterControl).
- Proven experience in managing teams and leading cross functional quality initiatives.
- Excellent written and verbal communication, reporting, and stakeholder management skills.