Mechanical Quality Engineer

This Role is based in Germany- Rotation Plan available

We are seeking an experienced Mechanical Quality 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.
  

Required Qualifications & Experience

• Bachelors degree (or higher) in Mechanical Engineering.
  
• 4 years of QA experience
  
• 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.
  

Next Steps

If you are interested in this role please apply directly or email your CV to