Summary
Overview
Work History
Education
Skills
Websites
Certification
Timeline
Generic
MONIKA BINKIEWICZ

MONIKA BINKIEWICZ

Advanced QA Professional
Hillerød

Summary

Quality Professional with strong problem-solving skills acquired through experience on the production line and participating in the implementation of new products and systems. Detail oriented and self - motivated. Good in working and collaborating with diverse team and different stakeholders. I work every day to increase quality performance and contribute to customer satisfaction. I identify risks and help to implement optimal and standardized solutions.

Overview

4
4
years of professional experience
5
5
Certifications
4
4
Languages

Work History

Advanced QA Professional

Novo Nordisk
07.2024 - 09.2025


  • QA Professional for expansion project at a new CMO supplier site
  • Review of protocols, reports, SOPs and project documentation
  • PQ batches approval
  • Overseeing the quality level of components used in Medical Devices
  • Maintaining quality contracts
  • Handling deviations through CAPA processes
  • Ensuring compliance with GMP standards
  • Change requests approval
  • Facilitating continuous improvement
  • Participating in supplier's audits
  • Managing and distributing quality documentation through SQL database

Quality Engineer

Danfoss
05.2022 - 06.2024
  • Identifying problems and recommending new processes to improve efficiency and reduce costs
  • Sharing lessons learned across organization
  • Performed quality inspections and drafted reports to detail non-conforming material issues.
  • Leading Six Sigma Project to reduce scrap
  • Support of design changes implementation
  • Managing Risk Assessments
  • Solving internal quality problems on production line
  • 8D methodology, Gemba Walks
  • PFMEA, SOP, Control Plans reviews
  • Continuous improvement
  • Quality documents updates and preparation
  • Team leader in 8D competition: 1st place in Danfoss Refrigeration and Air Conditioning
  • Support in customer complaints
  • Claims related to internal suppliers
  • Daily cooperation with MT, Supervisor, Logistic, Maintenance, Engineering, Product Management
  • Quality support in MES/MOM
  • Implementation of new products on production line
  • SPPAP process

Trainee

Danfoss Poland Sp. z o.o.
06.2021 - 08.2022
  • Holiday Trainee Program in Danfoss Poland
  • Claim handling process support
  • Claim Handling Time analysis project (analysis, evaluation, improvement proposals)

Supplier Quality Assistant

Danfoss Poland Sp. z o.o.
09.2021 - 05.2022
  • Claim handling process support
  • SAP: supplier claims, customer claims
  • Initial claim report
  • Communication with suppliers and claim creators
  • Credit notes processing / overview
  • Maintain local claim database
  • Leading weekly claims review
  • Support in solving of quality issues: failure reproduction, potential root cause identification, analysis of returned parts vs specification
  • Follow-up meetings with suppliers: bi-weekly, daily, ad-hoc
  • Support in SPPAP process
  • Appearance Approval Reports (AAR)
  • Support in SAP processing
  • Data analysis and report preparation: 8D evaluation, Claim Handling Time, suppliers overview
  • Support for CMQ Quality Team

Education

Bachelor of Chemical and Process Engineering -

Warsaw University of Technology
10.2022

Skills

  • Quality Assurance

  • Analytical Problem Solving

  • Technical Support

QMS

undefined

Websites

Certification

SanGenShugi / FTA - Danfoss Internal Training - Present

Timeline

Advanced QA Professional

Novo Nordisk
07.2024 - 09.2025

Quality Engineer

Danfoss
05.2022 - 06.2024

Supplier Quality Assistant

Danfoss Poland Sp. z o.o.
09.2021 - 05.2022

Trainee

Danfoss Poland Sp. z o.o.
06.2021 - 08.2022

Bachelor of Chemical and Process Engineering -

Warsaw University of Technology

Similar Profiles

CREATE PROFILE
MONIKA BINKIEWICZAdvanced QA Professional