O

Head of Product Compliance & Quality

Orbem • Germany
Relocation
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Drive product quality management and regulatory compliance for Orbem's hardware, software, and AI systems across EU, US, and global markets. Lead and scale the product compliance team while embedding compliance and quality into the product lifecycle through cross-functional collaboration. Requires 10+ years in compliance/quality management with leadership experience, broad knowledge of UL508A, NFPA79, and CE marking, and hands-on CAPA/root-cause practice.

Key Highlights
Lead product compliance and quality management across EU, US, and global markets
Secure NRTL approvals and CE marking under Machinery Regulation and EMC Directive
Own CAPA, root-cause analysis, and design change loop from field nonconformances
Lead and scale the product compliance team
10+ years compliance/quality experience with leadership background
Key Responsibilities
Own compliance roadmaps for international market access, securing NRTL approvals and CE marking
Mentor and grow the product compliance team
Partner with product development, Field Operations, Supply Chain, Procurement, and Legal to embed compliance into the product lifecycle
Own nonconformance and CAPA processes through root-cause analysis into updated risk assessments and design changes
Translate regulatory frameworks into clear guidance for multidisciplinary teams
Maintain compliance guidelines and champion system validation processes
Own regulated product documentation including manuals, safety markings, and translations
Technical Skills Required
UL508A/NFPA79 CE Marking CAPA
Benefits & Perks
Stock Options
Relocation Support
Learning & Development budget (€1,750/year)
Fitness Membership
Childcare Reimbursement
Deutschland Ticket subsidy
Flexible Hours & Home Office
WFH Perks (€185 + monitor)
30 Days Paid Leave
Work From Anywhere (up to 60 days/year)
Nice to Have
Direct domain experience with industrial automation systems in food processing or agricultural sectors
Academic background in Electrical Engineering, Mechanical Engineering, or related technical discipline

Job Description

Orbem uses AI to industrialize MRI, delivering non-invasive insight into everything from fruits to eggs to the human body. We are transforming what is becoming the world's largest biological dataset into actionable intelligence to reduce waste, increase quality, and accelerate the shift toward a more sustainable and healthier future.

Headquartered and founded in Munich, Germany, with an office now in Houston, Texas, our world-class team is scaling inside-out technology to transform how humanity sees and understands biological matter.

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