Agnieszka Dzikuc
Sr SQE
Lausanne
Profil professionnel
Sr Supplier Quality Engineer who enjoys turning complex ideas into manufacturable reality. Brings strong experience in medical devices, aerospace, and automotive, with a mindset focused on partnership, problem-solving, and practical compliance. Acts as a bridge between engineering, suppliers, and operations to help new projects move from concept to robust production. Combines regulatory discipline with a collaborative and solution-driven approach, removing obstacles rather than creating them. Translates technical and regulatory requirements into clear actions suppliers can follow, supports teams through challenges, and helps build the capability needed for long-term growth.
Vue d'ensemble
15
15
years of professional experience
3
3
Industries
Expérience
Senior Supplier Quality Engineer
Distalmotion SA
Lausanne
02.2021 - 11.2025
- Leads supplier development and qualification activities for Class II medical devices.
- Qualified new suppliers through APQP and PPAP, increasing supply capability for precision machining, molding, thermoforming, welding, and silicone injection.
- Built structured supplier performance monitoring through KPI dashboards and ERP integration.
- Improved supplier readiness for new product industrialisation, enabling six new instrument versions to reach manufacturing maturity.
- Strengthened CMO partnership by improving cleanroom workflow, assembly quality, and process controls.
- Led PFMEA sessions and supplier risk reviews to support new project implementations and its industrialisation.
- Drove process validation with suppliers, including IQ/OQ/PQ planning, AQL sampling, and critical process controls.
- Supported FDA clearance preparations by aligning CMO and supplier documentation, product traceability, and validation evidence.
Supplier Quality Assurance Engineer
Collins Aerospace
07.2017 - 01.2021
- Developed suppliers through audits, capability assessments, and AS9100-aligned validation.
- Reduced recurring defects by applying 8D and Zero Defect Plan tools.
- Improved supplier delivery performance through targeted process improvements.
- Collaborated with suppliers to secure readiness for aerospace NPI programs.
- UK
Project Quality Leader
Faurecia Innenraum Systeme
03.2017 - 06.2017
- Defined quality and process requirements for new components.
- Created APQP plans and coordinated with suppliers during development.
- Germany
Supplier Quality Assurance Engineer
Faurecia Legnica S.A.
05.2013 - 02.2017
- Ran supplier containment, nonconformance analysis, and improvement programs.
- Performed process, product, and capacity audits.
- Developed inspection and control plans for suppliers.
- Poland
Incoming Goods Inspector
Faurecia Legnica S.A.
05.2011 - 05.2013
- Conducted incoming inspections and ensured specification compliance.
- Coordinated PPAP sample and containment activities.
- Poland
Formation
MSc - Operations & Supply Chain Management
Rushford Business School
Geneva, CHPostgraduate - Managing Business
University of Economics
Wroclaw, PLBSc - Managing & Production Engineering
Witelon State University
Legnica, PLCompétences
- Supplier Development
- APQP & PPAP
- Process Validation (IQ/OQ/PQ)
- Risk Management (ISO 14971, PFMEA)
- Supplier Audits
- CMO Oversight
- NPI & Design Transfer
- AQL Sampling
- Cleanroom and Assembly Operations
- Lean and Continuous Improvement
- ERP and KPI Governance
- Regulatory Compliance (ISO 13485, FDA QSR, AS9100)
Certificats
- ISO 13485 Internal Auditor
- ISO 13485 Foundation
- AS9100 External Auditor
- Supplier Control and Outsourcing (Key2Compliance)
- Cleanroom Fundamentals – 20h course
- Sampling for Medical Devices
- Process Validation for Medical Devices
- MDR (EU 2017/745)
- Quality Management for Medical Devices and ISO 13485
- Software for Medical Devices and IEC 62304
- Risk Management (ISO 14971)
- AQL Sampling Methods
- IATF 16949 (knowledge)
- Vinyasa Yoga teacher- 200h
Interests
- Non-fiction reading
- Bouldering
- Theatre
Languages
Polish
Bilingue
English
Opérationnel
French
Intermédiaire
German
Débutant
Chronologie
Senior Supplier Quality Engineer
Distalmotion SA
02.2021 - 11.2025
Supplier Quality Assurance Engineer
Collins Aerospace
07.2017 - 01.2021
Project Quality Leader
Faurecia Innenraum Systeme
03.2017 - 06.2017
Supplier Quality Assurance Engineer
Faurecia Legnica S.A.
05.2013 - 02.2017
Incoming Goods Inspector
Faurecia Legnica S.A.
05.2011 - 05.2013
Postgraduate - Managing Business
University of Economics
BSc - Managing & Production Engineering
Witelon State University
MSc - Operations & Supply Chain Management
Rushford Business School