MONIKA DOBROWOLSKA

Manage the QA element of process and technological improvements, NPI and technology/product transfers in conjunction with local Quality, Operations, and R&D personnel, ensuring timely communication to all stakeholders to effect successful project completion.

• Quality lead for NPI and technology projects transferring into production by collaborating with cross-functional teams, maintaining high standards of quality and compliance, to achieve project success (capacity expansion in Ti3D, CMM's optimization).
• Compile, review/approve, and execute validation plans, protocols and reports for new products, processes, and software. Ensure correct implementation as per standard validation procedures. Revalidate as required due to engineering changes, deviation analysis, or upgrades in systems and materials.
• Develop and utilize PFMCA and other QA risk analysis techniques in order to minimize potential risk during development and implementation activities.
• Liaise with R&D to ensure Critical to Quality Characteristics are agreed upon and documented for all New Product Development
• Lead design for inspection activities for all new product introductions to ensure the latest technology is available to reduce human error (LVR).
• Provide technical assistance to carry out problem analysis/non-conformance investigation as required, and define through negotiation, effective corrective actions.
• Assist in problem-solving for new products and established production processes, enabling a reduction in compliance risks, scrap, and reprocessing.
• Assist in the development, review, and approval of product, gauge, tooling, and fixturing drawings.
• Successfully executed Safety Management System driven by EASA regulations, including risk evaluation, action plan establishment, and change management, achieving 100% adherence to schedule.
• Performed testing to determine functionality or optimization.
• Led and motivated a high-performing quality team of 11, resulting in a 30% increase in productivity. Streamlined responsibilities by removing non-quality tasks, enhancing team focus and efficiency. Developed and nurtured talent within the quality department, significantly boosting overall morale and productivity.
• Reduced COPQ from 4% to 1.1% YTD by identifying key contributors and implementing effective 8D-driven improvements.
• Streamlined metallurgical lab processes by deploying new, precise equipment, resolving ambiguities within customer specifications.
• Enhanced de-masking and cleaning processes, achieving a 70% reduction in defects during de-masking and 100% during cleaning of TBC coating.

• Led the Quality Department to achieve business objectives by ensuring the delivery of the safest and highest quality product in compliance with customer, regulatory, and industry standards.
• Led a team of 11 employees, ensuring high productivity and excellent customer service by enhancing team morale and retention through recognition programs and career development opportunities.
• Secured necessary quality resources to fulfill the annual targets described in the business manual.
• Ensured compliance with regulatory requirements, EASA, IAA/FAA, and industry standards AS9100 by maintaining and continually improving the site QMS.
• Owned and managed the internal, external, and customer audit program, ensuring compliance with industry standards.
• Achieved and sustained certificates of compliance by successfully completing standard and regulatory audits such as ISO AS9100D, EASA, IAA/FAA, NADCAP, and NDT.
• Developed strategy for SMS implementation in compliance with EASA regulations, building and leading a dedicated SMS team. Evaluated and mitigated risks through SRB meetings, ensuring risk levels remained appropriately low by implementing corrective actions.
• Investigated and resolved issues from occurrence reporting and customer feedback, enhancing overall system compliance.
• Managed laboratory activities for product testing, quality control, validation, and NPI in accordance with technical specifications. Ensured all analysts were cross-trained and fully understood requirements. Stepped into the analyst role when necessary to maintain workflow continuity.
• Collaborated with various departments to address and resolve technical issues, ensuring effective problem-solving and process improvement.
• Supported incoming and final visual inspections by providing training and clarifying customer requirements on technical specifications.
• Provided strong customer support by promoting and facilitating the 8D program, ensuring effective resolution of issues.
• Executed comprehensive audits with customers and peers, reinforcing adherence to quality and compliance protocols.
• Analyzed Cost of Poor Quality (COPQ) to determine its financial implications.
• Manage the budget for the quality department, encompassing CAPEX projects, calibration, training, and resources.
• Review and approve internal documentation, external manuals, repair schemes, drawings, and quality specifications.
• Enforced customer service standards and resolved customer problems to uphold quality service.
• Created monthly reports for senior management, summarizing quality, operational performance metrics.
• Optimized the quality system through continuous improvements, ensuring consistent compliance with industry regulations.
• Directed the control of internal and external documents, ensuring adherence to compliance and quality assurance protocols.
• Enhanced workplace health and safety by adhering to all health and safety laws, standards, and ISO guidelines. Assists with safety incidents, investigations, and reporting when required.

• Led quality assurance for various projects, i.e.,. CAPEX undertakings following GAMP5 guidelines, including URS, FDS, pFMEA, and engaged in FAT and SAT; Compliance Program: MDR, UDI – labeling compliance, rebranding, material change – injection molding, extrusion, blow molding.
• Conduct validations of processes and equipment in alignment with regulatory guidelines and GXP compliance.
• Coordinate documentation processes to facilitate prompt project completions.
• Lead group of three inspectors on various projects.
• Execute and approve MVP TQ, IQ, OQ, PQ, and VR's validation documentation.
• Managed coordination of validation efforts involving packaging materials, CAPA, and NPI
• Determination of process capability via statistical analysis (MSA, Cpk, Ppk).
• Review and update the Control Plan, Process Map, and pFMEA, and resolve deviations.
• Support external accreditation audits (TUV, FDA, SDSAP).