Matt Rydzik, Mba Email & Phone Number

Branchburg, New Jersey, Us

• Assist pharmaceutical companies in the entire lifecycle of combination products. Consult on feasibility studies, test method development/ validation, design verification, process verification, risk & quality management, and product launch for combination products (ISO 11040, 11608, USP 1207, USP 788/ 787).• Establish relationships with Pharma partners to devise groundbreaking solutions in the healthcare industry.• Consult on deterministic Container Closure Integrity (CCI) test method strategies. • Conduct comprehensive market analysis to identify emerging trends and opportunities, informing strategic decision-making and driving business growth.• Prepare customer proposals, NDAs, service agreements, testing plans, and statements of work with company technical experts to support customer combination product development & testing requirements.

Franklin Lakes, New Jersey, Us

• Supports Medication Delivery and Catheter Care product families. Core team member on the Quality Packaging team experienced in ensuring product design compliance with FDA regulations, international standards/regulations, internal procedures, and adhering to packaging requirements as per ISO 11607. • Guides the Innovation Team on feasibility studies, including induction/ heat sealing.• Accountable for supporting New Product Development, Product Maintenance (Sustaining), and Cost Savings. Consults on DOE Methodology, Optimization, Statistical Analysis Tools, Minitab interface, Design Plans, and Design Control. Reviews electronic DHF and ensures its completeness.• Coordinator for Engineering Change Controls for Sustaining Projects initiated with multiple sites internationally.• Consults on Design Verifications, Process Validation Activities, Deviations, and Risk Assessments.• Provides guidance to manufacturing sites overseas on appropriate project steps with the Design Unit; mentor on DHF control, adequate documentation practices, and design control steps within multiple projects. Provides expertise on root-cause analysis techniques and non-normal data assessments/acceptance.• Member of the Quality Assurance team that drives profitable growth with the right product mix while transforming cost-position and focus on improving total GP $ by >$100M.• Governs Spec Deviation and Supplier Qualification activities in compliance with internal procedures and regulations.• Member of a Review Board (Independent Reviewer for internal projects, 510k pre-submission reviewer, DHF reviewer including Inputs, Outputs, Design Verification, Validation, and Transfer).

Gothenburg, Se

• Team member for manufacturing site transfer (planning, validation, improvements).• CAPA Owner (Investigation, Root Cause Investigation, Action Implementation, Dissemination). • Lead design change and process improvement for IABs and Heart-Lung Machine Kit Components.• Utilize Project Management Skills and Software to assess, track, and manage multiple process validation projects.• Assist with third-party and internal audits (Auditee for Statistical Techniques/ Sampling Plan Audit)• Assist with screening applications, interviewing candidates for Production Engineering positions, and onboarding process.• Train new employees on the validation concept (including pFMEA, risk management, sampling plans, and statistical techniques).• Advise on compliance with 21 CFR Part 820, EUMDR, and ISO Standards.• Ensure Design Control, Process Control, and support New Product Development.

Gothenburg, Se

• Formulate and execute Installation Qualification (IQ), Operational Qualification (OQ), Process Qualification (PQ), and Test Method Validation (TMV) protocols.• Write notebook studies and verification protocols per approved validation procedures that challenge parameters and output of a process.• Write final / summary reports. Assure that the acceptance criteria related to protocols are met. Write deviation reports as required upon validation failures. Analyze variable and attribute data.(Skilled in statistical methods, statistical process control, and sampling plans.)• Use creative and critical thinking to devise new approaches to solve technical problems and leverage understanding of engineering principles, advanced engineering methods, data, and judgment.• Contribute to a culture of innovation by proactively generating novel concepts to improve current product performance.• Responsible for training and educating junior production engineers and help to create a positive and precise atmosphere within the engineering team.• Assist with the implementation of continuous improvement processes for efficiency to create a Lean Manufacturing environment.• Work together with senior Engineers to conduct Design of Experiment (DOE).• Having exposure to robotics automation and digital process automation technologies.

Gothenburg, Se

• Create and develop quality system documents including specifications for production supply items and perform standard operating procedure updates in accordance with current manufacturing practices • Utilize SolidWorks in the development of new designs and components for manufacturing tools• Evaluate and implement improvements for part and assembly design through Engineering Change Notice process including bill of material cleanup• Execute uses of Instron, Micro-Vu Measurement System, Micrometer, and Multimeter and perform routine leak testing and inspection• Collaborate with team members to verify and report data to the FDA's Global Unique Device Identification Database (GUDID)

San Francisco, California, Us

• Consulted on ISO 13485 and 9001 certification requirements. Drafted Quality Systems Procedures prior to Stage 1 & 2 audits. • Worked within multiple industries as a documentation specialist, advised on compliance with FDA & EUMDR regulations, and successfully accomplished multiple documentation projects. • Developed and designed labels used for supplement bottles.• Created eBooks and video advertisements for publishing format.• Translated documents from Polish to English and from English to Polish.

Nj, Us

• Provided training to students on using various software tools and applications efficiently (Including Microsoft Word, Advanced Excel, C/C++ compilers, etc.)• Assisted professors in the issues related to software installation, troubleshooting, and upgrading new teaching methods in terms of technology.• Calibrated school equipment.• Repaired hardware and software associated with desktop computers.

Executive Master Of Business Administration (Mba), Business Administration And Management, General

Bachelor Of Science (Bs), Biomedical/Medical Engineering

Engineering Science