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.
• 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.
• 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.
• 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.

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.

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.
• 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.

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