Laura Lied

Operations & Supplier Quality Manager

Principal/Lead Quality Planning Engineer. Administrator of Change Control, Risk Management & Validation Systems.Coordinates and supervises the improvement activities of the Quality, Engineering & Manufacturing departments to assure the quality of the products and processes; Provide support to validations, transfers, improvements of the products & manufacturing processes carried out by other functions. Develops and implements projects for the continuous improvement of Quality (or related) systems. Approves changes and protocols to ensure compliance with the procedures and regulations applicable and coordinates the correct implementation and operation of the Advanced Quality Planning (AQP) in the Facility. Supervision of 9 direct reports (Quality Engineers). Responsible of First Time Quality Program Deployment, Facility Remediation Plan & Calibration Department. Expertise facilitating front and back rooms for Notified Body Inspections

Responsible of: Create & Update Facility Master Validation Plan, Ensure Validation/Change Control & Risk Management Systems Compliance, Evaluate & Control Risk associated to projects implementation, Verify & Approve Validation activities, Support to Complaints investigation, Update APQP (Process Flow/FMEA/QCP as required), Ensure properly validation requirements for projects implementation, Support to Audit/Transfers/CAPA/Corporate/ Improvement processes, Supervision of Quality Technicians.

Coordinates and supervises the quality operations activities (Product and Process) until Final disposition of products. Perform Trend Analysis in order to identify and address improvement activities. Provide support to validations, transfers, improvements of the products & manufacturing processes that are aligned to operation improvement & Plant Strategic Plan.

Subassembly Area Lead Engineer, Supervision of Process Technicians, Process & Project Engineers of the Manual Subassembly Area, Technical Support to BU, Approval of Validations IQ / OQ / TMV/ PQ / PPQ / ECRS, Support to Corporate Projects, Management of CAPA (DMAIC)

Validation of Equipments and Processes, Support to Corporate on Transfers Projects (Products/Process), Technical Support to BU, Supervision of Process Technicians and Process Engineers, Validation of Methods for Product Testing, Impact Analysis of projects Implementation, Management of Scrap Reduction Projects

Process Control of Subassemblies Area, Financial Indicators Analysis, Implementation of Improvements in Manufacturing Process, Validation of equipments, Changes of Operational Parameters of Equipments, Participation in the Creation of PFMEA, QCP

Sterilization Chamber using E-Beam Technology Transfer Project implementation, Industrial Engineer for Fenwal Transfer PR-DR, Transfer of products and equipment from Fenwal - San German/Maricao to Fenwal - Haina, Validation of new equipment/Manufacturing stations, Products and Processes, Analysis of Product Costs, Financial Analysis of Projects to be Implemented, Implementation of improvements in product / process assembly, Layout Changes for Projects Implementation.

Manufacturing Process Control, Financial indicators Analysis & Presentations to Management, Process monitoring, Capability Analysis, Improvements in the Scrap Indicators.

Internship Program, Departments: Manufacturing, Quality Operations, Materials, Project Engineering, Process Engineering.