Product Assurance Engineer (Manufacturing)

Location: Wackersdorf, Germany

Company

hirify.global develops engineered components and subsystems for mission-critical healthcare and advanced manufacturing applications, including minimally invasive surgery, robotics, and 3D metal printing.

What you will do

• Organize and coordinate internal, supplier, customer, certification, and surveillance audits.
• Implement audits, manage findings, and drive corrective and preventive actions for sustainable process improvement.
• Support NPI projects through risk assessments, FAI protocol approval, inspection and testing requirements, PFMEA, DFMEA, reliability testing, and assembly documentation.
• Manage supplier quality activities, supplier RMAs, defective product investigations, and corrective measures.
• Program, maintain, and operate CMM inspection programs, while supporting calibration and preventive maintenance processes for test equipment.
• Lead deviation permits, engineering changes, IQ/OQ/PQ and process validation, quality readiness for production transfers, and local quality reporting.

Requirements

• Bachelor’s degree in engineering or a related field, or technician training or comparable qualification.
• First professional experience in a relevant quality or engineering role.
• Experience with ISO 9001 and ISO 13485 management systems.
• Knowledge of Pareto analysis, Ishikawa diagrams, cost-benefit analysis, fault tree analysis, and FMEA.
• Technical understanding and an independent, careful working style.
• Teamwork and strong communication skills; measurement technology experience is desirable.

Culture & Benefits

• Work with engineering teams in Wackersdorf and Bedford within a global organization.
• Collaborative culture focused on teamwork, collaboration, and empowerment.
• Full-time employment supporting products used in healthcare and advanced manufacturing.