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

• Bachelor’s 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