Job Description
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
1. Lead QA activities across pharma and construction projects, ensuring compliance with GMP, GEP, ISO standards, and other applicable regulations.
2. Develop, implement, and maintain Quality Management Systems (QMS) to ensure adherence to project, client, and regulatory requirements.
3. Oversee mechanical system installations (e.g., HVAC, piping, pressure vessels) with a focus on quality and compliance in both cleanroom and construction environments.
4. Coordinate with multidisciplinary teams including engineering, validation, commissioning, construction, and operations to align quality standards.
5. Perform supplier and contractor audits, review quality documentation, and ensure proper IQ/OQ/PQ protocols are followed (in pharma).
6. Lead Non-Conformance (NC) investigations, CAPAs, and root cause analysis for deviations in construction or pharma environments.
7. Ensure all materials, equipment, and systems used in construction or manufacturing are installed and qualified to meet regulatory expectations.
8. Participate in project planning, risk assessments, and quality reviews from design through handover phases.
9. Serve as the primary quality interface with regulatory bodies and client auditors.
Required Qualifications & Experience
10. Bachelor’s degree (or higher) in Mechanical Engineering.
11. 4+ years of QA experience
12. Solid understanding of mechanical systems within GMP manufacturing and industrial construction.
13. Hands-on experience with validation, commissioning, and qualification processes.
14. Strong familiarity with regulatory standards such as FDA, EMA, MHRA, and ISO 9001.
15. Experience implementing or working with QMS platforms (e.g., TrackWise, MasterControl).
16. Proven experience in managing teams and leading cross-functional quality initiatives.
17. 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 careers@fohntechgroup.com
Requirements
Mechanical Quality Engineer