Alice Kustusch Email and Phone Number

Product Development Quality Engineering Support• Act as the primary Quality reviewer on verification and validation documents including protocols, reports, product requirements, specifications, risk management file, etc.• Provide strategic and content recommendations for verification and validation protocols and reports – testing to requirements, equipment qualifications, tool qualifications, etc.; support V&V activities by providing insight on sampling plans, techniques, testing methodologies, etc.• Guide the teams executing V&V protocols in accordance with the relevant V&V plans and defined schedules.• Review traceability of requirements, risk mitigations and V&V outputs • Lead resolution of deviations by investigating the cause of the deviations and implement any corrective or preventive actions.• Participate in and contribute to strategic discussions relating to future quality objectives• Work closely with R&D to develop or refine material and product specifications, including in-process testing, release testing and acceptance criteria.• Act as subject matter expert in audits and regulatory inspections.Other Quality functions• Assists in document control, training, inventory management, and other quality system functions as needed.• Identifies and drives improvements through initiation of CAPAs and NCRs. • Drafts SOPs and work instructions

• Quality System Management: Responsible for supporting EdgeOne ISO 13485-2016 compliant Quality Management System. Assisting and leading the development and remediation of client Quality Systems. Supporting internal and external audits, observations, and responses. Contributing to quality system development deliverables (i.e., procedures, CAPAs, complaints, etc.) for client specific projects. • Quality Review: Supporting quality review of laboratory documentation, including test protocols/reports and equipment and test method validation. Assisting in the review of data feeders including but not limited to internal and external audit observations, CAPAs, customer feedback, and management review to determine effectiveness of the quality system.• Design Control and Product Development: Owning the development and remediation of Design History Files. Assisting and leading design control deliverables (i.e. plans, risk assessment, verification and validation protocols and reports, etc.).

Medical Device Engineer - Disposables Manufacturing• Innovation: Served as manufacturing lead for transfer of product design history file (DHF) for newly acquired technology. Integrated DHF files and identified gaps in risk files and evidence of verification and validation.• Standards and Compliance: Lead engineer on team to update Luer design to comply with new ISO standard for IV Luers by identifying dimensional gaps. Updated requirements and risk files and completed design verification and mold validation.• Problem Solving and New Product Development: Manufacturing lead for new product development project. Created specifications and SOPs to support manufacturing plant to successfully transfer design and manufacture six new products. Identified supplier for new component and developed incoming and receiving specification test methods. Supported design and implementation of new test fixtures and other manufacturing equipment. Worked with project core team to identify design inputs and translate them to requirements on the component, product, and system level.• Quality Improvement: Determined root cause using analysis tools including cause/effect diagrams, IS/IS NOT tables, and 5-Whys diagrams. Performed design of experiments (DOE) to determine most effective solvent application fixture and method in response to a Nonconformance. Designed test method for determining subassembly bond strength and performed risk assessment to identify unidentified risk. The bond was strengthened by 500% and risk of subassembly disconnection was reduced to an acceptable amount.• Leadership and Simplifying the Complex: Subject matter expert on change control management, data statistical analysis, supplier notices of change (SNC), and CAPA/NCR. Worked with cross-functional team to create job aid for change control management quality system in order to simplify the process for new change owners. Served on team to identify unnecessary, time-consuming aspects of the SNC process.

Medical Device Engineer - Disposables Manufacturing• Life Cycle Management of Legacy Products: Project manager for projects involving Design History File management and change control ownership (SNC, design, and value improvement projects). Met project deadlines to avoid supply interruption. Project lead for over twenty SNCs and owner of forty change controls.• Verification and Validation: Study director and author of numerous verification and test method validation protocols and reports for legacy IV products. Wrote test protocols for non-interconnectivity testing (bench top and CAD analysis) per new ISO standard for IV Luers.• Navigating Regulation: Supported a technical file to CE Mark twenty-six products in order to attain regulatory coverage to continue selling in Australia and New Zealand. Met the project deadline and launched on time to avoid loss of sales.

Container R&D Engineering• Product testing including building and sterilizing PVC container systems, compressive and tensile force Instron testing, and leak and burst testing on bag/spike and medication port septum assemblies.• Writing protocols and reports, supporting CAPAs with root cause analysis and testing, DHF creation starting with design inputs from customer.• Supporting role in CAPA’s, design history file creation, and change control to legacy products

Research Technician in the Smeltzer Lab-Department of Microbiology and Immunology

Focused on maintaining cell culture, protein expression, molecular biology assays, and histomorphometry.

Focused on histology and biomechanics.