Orbem
Head of Product Compliance (f/m/d)
6 дн. назад
ГерманияSeniorHybrid
product quality managementregulatory compliancenrtl approvalsce markingmachinery regulationemc directiveroot-cause analysiscapa process
Lead product quality management and regulatory compliance for Orbem's systems across international markets. Manage and scale the product compliance team ensuring global standards and quality.
About the company
- International Environment: team with 40+ nationalities across 5 continents, driven by shared purpose solving complex challenges.
- Values: Own Every Challenge, Strive for Better, Imagine New Frontiers.
Responsibilities
- Own compliance roadmaps for international market access, securing NRTL approvals and achieving CE marking through the Machinery Regulation and EMC Directive.
- Mentor and grow the product compliance team, fostering a culture of continuous learning, fast delivery, and strong ownership.
- Partner closely with product development disciplines, Field Operations, Supply Chain, Procurement, and Legal experts to embed compliance and quality management seamlessly into the product lifecycle.
- Own the path from field and production nonconformances through root-cause analysis and CAPA into updated risk assessments, technical files, and design changes.
- Translate complex regulatory frameworks into clear guidance, facilitating alignment and smooth execution across multidisciplinary teams.
- Maintain structured compliance guidelines while adapting processes to support the fast-growing scaleup environment.
- Champion system validation processes to ensure product reliability.
- Take accountability for operator, installation, and maintenance manuals, safety markings, and translations as conformity deliverables, leading the technical writers who produce them.
Requirements
- 10+ years of experience in compliance and quality management and proven leadership experience, ideally within an agile scale-up or high-growth tech environment.
- Experience overseeing complex systems combining hardware, software, and AI, ideally involving special machinery or automation equipment.
- Hands-on root-cause practice (8D, FMEA, fault tree or equivalent) with a track record of field failures changing designs.
- Broad knowledge of international product compliance frameworks, specifically UL508A and NFPA79 approvals, and CE marking under the Machinery Regulation and EMC Directive.
- Defined quality and compliance requirements in stage-gate processes and built Design for Compliance and Design for Quality principles in product development.
- Track record of building, mentoring, and scaling technical teams.
- Strong cross-functional communication and stakeholder management skills with a collaborative leadership mindset.
- Comfortable defining frameworks for acceptance criteria and verification evidence including factory and site acceptance testing, calibration, and measurement traceability.
Nice to have
- Direct domain experience with industrial automation systems in the food processing or agricultural sectors.
- Academic background in Electrical Engineering, Mechanical Engineering, or related technical discipline.
Conditions
- Stock Options: share in company's success.
- Relocation Support: seamless support for relocation to Germany.
- Learning & Development: €1,750 annual budget for personal growth.
- Fitness Membership: access to Urban Sports Club or Wellpass.
- Childcare Reimbursement: support for Kita/Kindergarten fees.
- Deutschland Ticket: monthly subsidy towards public transportation costs.
- Flexible Hours & Home Office: work when and where it suits you.
- WFH Perks: €185 to upgrade home office plus external monitor.
- 30 Days Paid Leave and Personal Leave for important life moments.
- Work From Anywhere: up to 60 days per year.
- Ambitious fast-growing team working on breakthrough technology with freedom to lead projects and make impact.