Conformance Analyst - Domestic (background in medical devices (syringes, tubes), laboratory, manufacturing)

Conformance Analyst - Domestic (background in medical devices (syringes, tubes), laboratory, manufacturing)

• Ensures correct and timely Certificate of Conformity (CoC) issuance in relation to the productivity and quality targets of the Certification Center.
• Assess product and/or exporter risk levels, identification of product essential requirements and applicable standards following the Business Rules on conformity assessment, classification, import eligibility and process flows, Conformity Assessment Instructions (CAIs), and other related references.
• Provides quality and technically-based opinion on product standards and product classification and certification.
• Assists in the resolution of standards, classification and certification cases and other requests and or inquiries by utilization of technical expertise on specific goods or commodity

Qualifications

• University degree or equivalent professional qualification (*)
• With knowledge related to his/her field of expertise (Product design, manufacturing, testing, product research and specification).
• Preferably with background on the following fields: Toys, Medical Devices, Paper, Packaging, Textile
• Conformity assessment (accreditation systems, product certification, product testing, inspection protocols and industrial metrology)
• Industrial standardization concepts including international standards development and implementation, i.e. ISO, IEC, EN, ANSI, ASTM etc.
• Quality management system, e.g.: ISO 9001, ISO 22000, ISO/TS 16949 or similar systems.