Dariusz Planeta Email & Phone Number

Wayne, Pa, Us

• Recruit, develop, and lead the Design Assurance Engineering team to effectively drive the execution of Design Controls, Design History Files, Risk Management, Test Method Development and Validation, Design Verification/Validation, and Statistical Analysis for NPD and Sustaining projects• Led Design Verification and Validation activities, resulting in successful product launch and regulatory submission • Oversee lifecycle risk management activities and process post-market information about the Risk Management File • Provided input into corporate strategic initiatives and executed at a site level• Manage and improve Quality Systems with a focus on Design Assurance components – including design controls, risk management, design & and test method validation and design verification, post-market surveillance • Collaborated with R&D, Regulatory Affairs, and Quality teams to ensure alignment on project goals and regulatory requirements

Global, Global, Oo

• Provided Quality Assurance leadership to manufacturing operations and New Product Introduction teams• Trained and mentored engineers on the technical aspect of the Quality Management System• Established procedural governance of the Design and Development process• Led the design assurance from a Quality perspective to ensure the reliability of product designs, compliance to design requirements to support effective design transfers and product launches

• Provided subject matter expertise and consulted multifunctional R&D, engineering, quality, and regulatory management groups on all QMS categories, structural, technical, and statistical aspects from design/technical transfer, process development, validation, verification to process monitoring and post-production product lifecycle• Represented Quality during global projects with a focus on QMS structural development, new product/process introduction and manufacturing of the globally distributed CE marked Class II and Class III Medical Devices to conform to the ISO, EU Directives (MDD), global and local GMP, and other regulatory requirements• Site quality representative for EU MDR implementation• Analyzed data and created statistically driven sampling strategies as well as verified the efficacy of the existing ones by assessing process capabilities - from product design verification to process validation and production monitoring• Led, reviewed, and approved global project deliverables from validation strategies, protocols, and reports to process validation transfers to the manufacturing environment• Led and executed process and equipment validations (IQ, OQ, PQ) and test method validations • Evaluated hazards, performed risk assessments of the current systems with the implementation of strategies and action plans (CTQ cascade, FMEAs, critical control points, process capability mapping) • Led failure investigations and root cause analysis triggered by nonconformities (NC) or CAPA processes within and outside manufacturing, developing mitigation action plans and implementation• Site SME in statistics, process, and equipment validations

• Acted as quality and compliance lead in multiple commercial validation projects with a strong focus on regulatory requirements• Led risk assessment sessions for computerized systems and support technology developments• Continuously enhanced production processes by establishing and validating improvements throughout the entire product- and process lifecycle • Handled audit observations NCs and CAPAs• Facilitated quality recertification processes and surveillance audits

Hudson, Wi, Us

As a Metrology Engineer at Phillips-Medisize, I work in fast-paced environment in a quickly growing team. I was involved in a number of projects mainly focused on introduction and validation (IQ, OQ, PQ) of new processes from the design phase into the production phase as well as the introduction of process control techniques for existing processes and processes improvements. My main achievements and responsibilities include:- Managing projects and resource prioritization- Continuous improvement of productions processes - Development and execution of project plans for new products introduction - Developing and documenting new processes within Phillips-Medisize Netherlands: Gage R&R, Statistical Process Control (SPC), advance statistical analysis- Developing Validation Strategies and writing validation plans,- Validating of measuring equipment and software- Writing and updating Validation Protocols (IQ, OQ, PQ), and User Requirements Specifications (URS) for new equipment - Supporting Closure of CAPA’s and NCR’s - Internal consultant and trainer on statistical tools - Customer advice in creating sampling plans, understanding process variations capabilities, and SPC- Increasing awareness and knowledge about data analysis, Lean Six Sigma techniques, and processes control techniques and improvement at Phillips-Medisize Netherlands

Farmers Branch, Texas, Us

Voltea is a start-up company set up in 2006 which delivers innovative technology for water softening application - Capacitive deionization (CapDi), mainly for cooling towers and households. Voltea is an innovative company that keeps receiving many awards, the most recent is Technology Pioneer 2013.Working for a small start-up company gave me the opportunity to grow fast and develop a broad range of skills. As a Quality and Process Engineer, I was involved in the following projects:- Developing and scaling-up process of coated electrodes production- Process design for coated electrodes production- Implementing control system, reviewing existing data, and upgrading the process- Running quality improvement project (Lean)- Leading and documenting Risk Assessment sessions (FMEA) - Applying Lean Six Sigma tools for process control and variation reduction along with troubleshooting existing process - Work closely with process operators in order to improve processes- Reviewing lab results and approving product releases - Reviewing production plant documentation - Realising COAs of finished products- Development and validation of methods for coated electrodes quality control

Brzeg Dolny, Dolnośląskie, Pl

- Development of washing fluids- Rheological analysis of fluids- Sythesis of anti corrosive agents