Conformance Analyst - Domestic (background in medical devices (syringes, tubes), laboratory, manufacturing)
Core
Ensures timely issuance of Certificates of Conformity (CoC) and assesses product/exporter risk levels based on conformity assessment rules and standards.
Role type
Conformance Analyst (Medical Devices, Laboratory, Manufacturing)
Builds
Certificates of Conformity (CoC) and technical opinions on product standards/classification
Domain
Regulatory compliance, conformity assessment, industrial standardization
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Conformity assessment, industrial standardization concepts, quality management systems, product design knowledge, manufacturing knowledge, product testing knowledge, product research knowledge, specification knowledge, risk assessment, classification expertise
Preferred skills
Background in Toys, Medical Devices, Paper, Packaging, Textile
Technologies
ISO, IEC, EN, ANSI, ASTM, ISO 9001, ISO 22000, ISO/TS 16949
Responsibilities
Ensure correct and timely Certificate of Conformity (CoC) issuance, Assess product and/or exporter risk levels, Provide quality and technically-based opinion on product standards and classification, Assist in resolution of standards, classification and certification cases
Seniority
Mid-level, technical specialist
