Release Technician

hace 4 días

Cartago, Costa Rica GRUPO PRESELECCION ELY S.A. A tiempo completo

Working under mínimal supervision, reviews and approves DHRs (Device History Records) and other records for finished disposables and equipment devices to ensure they meet established regulatory and quality guidelines prior to release for sale. Release Coordinators also review, approve, and coordinate special release scenarios such as QC Holds, Controlled Distribution, and Control of Distribution SAP transactions, where appropriate. Responsibilities: Working independently to coordinate and obtain all required documentation for a complete DHR. Provides accurate and timely turnaround time for approval on product release documentation and SAP release transactions. Responsible for Controlled Distribution, Control of Distribution and Quality Control Holds. Supports internal efforts to improve timeliness and ensure product quality to external customers. Interprets, executes, and recommends modifications to operating policies, SOPs, and WINs, where appropriate. Supports customer requests for established product certificates (Certificates of Compliance). Updates and maintains all product release indices, where appropriate. Supports non-US based facilities in meeting Quality System and regulatory requirements. Maintains regulatory required records per record retention requirements. Involvement in internal and external quality audits regarding Release paperwork, SAP transactions, and Policies/SOPs/WINS. Balance and prioritize essential daily tasks with longer term continuous improvement projects within the Release Coordinator scope.

**Requisitos**:

  • Quality Technician Iii

    hace 7 meses

    Provincia de Cartago, Costa Rica Boston Scientific Corporation A tiempo completo

    **Work mode**:Onsite**Onsite Location(s)**:Cartago, CR**Additional Locations**: Costa Rica-Coyol**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance** - At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some...

  • Quality Product Technician Turno A-b-c

    hace 6 días

    Cartago, Costa Rica GRUPO PRESELECCION ELY S.A. A tiempo completo

    JOB SUMMARY Working under mínimal supervision, Quality Product Technicians are responsible for testing materials and finished products to ensure they conform to all applicable laws and company standards. Quality Product Technicians test products across the three stages of production (before, in-process, and final) to ensure quality levels are met. Quality...

  • Quality Engineer Ii

    hace 1 semana

    Provincia de Cartago, Costa Rica Edwards Lifesciences A tiempo completo

    Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution. Key Responsibilities: - Investigate moderately complex manufacturing product quality and compliance issues...

  • Quality Engineering Ii

    hace 5 días

    Provincia de Cartago, Costa Rica Edwards Lifesciences A tiempo completo

    Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution. **Key Responsibilities**: - Investigate moderately complex manufacturing product quality and compliance issues...

  • Engineer Ii, Quality

    hace 7 meses

    Provincia de Cartago, Costa Rica Edwards Lifesciences A tiempo completo

    Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution. **Key Responsibilities**: - Investigate moderately complex manufacturing product quality and compliance issues...

  • Engr I, Manufacturing QA

    hace 7 días

    Provincia de Cartago, Costa Rica Edwards Lifesciences A tiempo completo

    Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution. **Key Responsibilities**: - Investigate basic manufacturing product quality and compliance issues (e.g., CAPA,...

  • Supervisor Ii, Qe Receiving Inspection

    hace 7 meses

    Provincia de Cartago, Costa Rica Edwards Lifesciences A tiempo completo

    Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution. **Key Responsibilities**: - Investigate moderately complex manufacturing product quality and compliance issues...