Mechanical QA Lead

Limerick, Ireland | Posted on 02/18/2026

We are seeking an experienced Mechanical QA Lead 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.

• 
  
• 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.
  
• 7+ years of 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. xcfaprz
  
• Excellent written and verbal communication, reporting, and stakeholder management skills.