Elena (Rodica) Chis
Plant Quality Manager
Experience
Plant Quality Manager
BHC Gummi-Metall GmbH
- Reviewing customer requirements (Quality Agreements) and implementing process and product quality measures within the approval processes (start-up support and initial samples according to PPF/PPAP) under APQP
- Main contact for quality-related issues at the site
- Implementing supplier quality support and development
- Ensuring compliance with all quality-specific requirements such as incoming and outgoing inspections, initial sample test reports, quality work instructions, inspection plans, and control charts
- Customer contact for complaint management and handling using Quality Core Tools: 8D report, 5 Why, Ishikawa analysis
- Active use of quality tools: control plan, PFMEA, inspection plan, EMPB, drawings, collecting and analyzing statistical data, R&R, MSA, SPC
- Conducting internal system, product and process audits according to VDA 6.3 and VDA 6.5
- Responsible for certification of the quality management system IATF 16949, occupational health and safety ISO 45001, and environmental management ISO 14001
- Supervising, goal-oriented leadership and development of a 10-member team
Project Quality Manager – Development
Prysmian
- Managing projects involving customer quality issues and related contractual agreements according to Amprion requirements
- Conducting FAT with the customer at the Gron facility in France
- Coordinating the creation of project quality plans, ITP and MTPs, quality control plans and project quality procedures together with the plants
- Ensuring compliance with requirements and relevant standards and regulations (IEC 62895; IEC 60332; IEC 60754; IEC 62067; IEC 60794) while involving internal and external stakeholders
- Collaborating with manufacturing plants on product quality and customer relations
- Planning and conducting quality audits of project processes and activities, production facilities, suppliers and ISA
- Following up on customer quality audits, handling nonconformities and complaints according to ISO 9001
- Promoting project improvements through the lessons learned method
- Regular analysis of project data (e.g., project goals, performance indicators, nonconformities, complaints) and corresponding reporting
Lecturer for Regulatory Affairs & Quality Management Systems – Medical Technology
Habmann Akademie / Habmann AufstiegsAkademie
- Teaching advanced content on design control principles and regulatory frameworks for medical devices according to ISO 13485:2016, ISO 14971, MDR, FDA QSR, IEC 62304
- Training on risk management methods including harmonized standards, hazard analyses, clinical evaluation, CE marking, and creation of technical documentation (Design History File, Device Master Record, Device History Record)
- Teaching in the areas of supplier management, auditing practice (VDA 6.3 / ISO 9001), GxP compliance and hygiene standards in the medical environment
- Preparing, conducting and evaluating lessons based on real regulatory requirements and current quality standards
- Mentoring and coaching professionals with a focus on practical quality understanding and cross-functional work in the medical technology sector
- Using case studies, video conferences and real-life scenarios for active participant engagement
- Assessing performance through exams, project work and analysis of technical documents
Head of Quality Europe for China – Fuerda Smartech Ningbo
ANÜ-Eurotriade
- Quality planning and support for OEM projects (Audi, VW, Daimler, Skoda)
- Point of contact for OEMs, auditors and suppliers focusing on quality topics
- Implementing European quality standards in Chinese plants (Cixi/Fuerda) according to IATF 16949, VDA 6.3 and VDA 2
- Supplier development and auditing according to VDA/IATF (e.g., BIA Wuxi, Geshi, Smartech, Heitec)
- Managing Q-service providers (Q3) for complaints
- Analyzing, planning and optimizing manufacturing and development processes using core tools (8D, FMEA, Ishikawa, Control Plan)
- Conducting and supporting system and process audits and laboratory qualification according to ISO 17025
- Supporting prototype development, quality assurance and project management
- Implementing and certifying the quality management system according to IATF 16949 at the plant
Program Quality Leader / Head of Quality Planning – Development
Faurecia Angell Demmel Lindau
- Defining quality objectives and establishing the quality management plan according to IATF 16949, VDA 6.3 and VDA 2
- Project management and direct interface with BMW
- Strategic coordination of project and process objectives
- Managing quality gatepoints including safety, environmental and PPM requirements
- Creating control plans, requirement specification reviews and risk scenarios (FMEA, PPM, critical characteristics)
- Approving DVP & PVT and monitoring their completion
- Planning and conducting SPC and coordinating gauges
- Supplier development, auditing and evaluation according to VDA 6.3
- Ensuring compliance with agreed quality targets with the customer
Plant Quality Manager
EKR Elektrokontakt Romania
- Leading and developing a team of 25 in quality management
- Strategic and operational responsibility for the QM department according to IATF 16949, VDA 6.3/6.5/2
- Implementation, monitoring and continuous improvement of the QM system (incl. TQM, KPI, APQP)
- Conducting and leading internal/external audits (processes, customers, suppliers)
- Managing quality agreements with customers and suppliers
- Ensuring measurement equipment management, inspection planning and calibration
- Active use of relevant QM methods (FMEA, SPC, MSA, 8D, 5Why, Ishikawa)
- Responsibility for project launches and plant relocations, including document review
- Implementation and certification of the quality management system according to IATF 16949
Production Associate – Medical Technology
IPPS Timisoara
- Working in the production of Class I medical devices according to MDR (surgical drapes, surgical instruments, ventilators, wound care materials, stethoscopes, protective masks, non-motorized wheelchairs)
- Applying quality requirements according to ISO 13485, including managing material flow, traceability and documentation
- Contributing to the introduction of new technologies in a developing regulatory production environment
- Collaborating with IT to implement production-ready software solutions (VPPS) for production control (SAP)
- After completing my engineering degree in 1992, taking on technical tasks as a process engineer (material planning, production control, capacity balancing)
- Participating in quality-related processes: complaint management, incoming inspection, outgoing goods control
- Performing risk analyses according to ISO 14971 and contributing to the development of regulatory production processes
Summary
Experienced graduate engineer in precision mechanics and mechatronics with a focus on optics and optoelectronics in medical technology. For over 20 years, I have held leadership roles in quality management – focusing on product excellence, compliance and continuous improvement in high-tech sectors such as automotive, industrial and medical technology.
Graduate engineer in precision mechanics and mechatronics with over 20 years of professional experience in quality management – in the medical device, automotive and manufacturing industries, working in Europe and Asia.
Solid expertise in establishing and implementing quality management systems (including ISO 13485, ISO 14971, ISO 9001, IATF 16949, VDA 6.3), particularly focused on design control, risk analyses, validation/verification (V&V) and technical documentation.
Successful leadership of international quality projects from the prototype phase to series production with cross-functional development teams. Skilled in audit strategies, supplier development, product safety requirements, FMEA, PPAP, SPC and APQP.
As a certified auditor, I also teach at the Habmann Academy Stuttgart in the areas of regulatory affairs, quality management according to ISO 13485 and risk management according to ISO 14971 – with a strong practical focus.
My profile is defined by strong communication skills at all levels, empathetic leadership experience and strategic thinking – combined with a passion for quality and continuous improvement in development processes.
Skills
Implementation And Auditing Of Qms: Iso 13485, Iso 14971, Iso 9001, Iatf 16949, Vda 6.3
Application Of Design Control Requirements In Medical Device Development
Execution Of Validation And Verification Activities (V&v)
Creation And Review Of Technical Documentation: Design History File, Dmr, Dhr
Use Of Quality Core Tools: Apqp, Fmea, Ppap, Msa, Spc
Product Safety Requirements And Risk Management According To Mdr, Fda Qsr, Iec 62304
International Project Management In Europe And Asia
Supplier Development And Audit Strategies (Including Aiag Cqi Standards: Cqi-9, Cqi-11, Cqi-12, Cqi-15, Cqi-23)
Training And Guiding Teams On Regulatory Requirements And Quality Principles
Intercultural Communication And Stakeholder Management
Leadership Experience In Cross-functional Teams
Strategic Thinking, Strong Analytical Skills And Diplomatic Skills
Ms Office Suite: Word, Excel, Powerpoint, Outlook, Visio
Sap In Quality Management
Lotus Notes
Babtec
Ppms
Lucidchart
Languages
Education
National School of women managers from Romania
Post University Degree · Timișoara, Romania
Tehnical University of Timisoara
Graduate Engineer, Precision Mechanics and Mechatronics · Precision Mechanics, Mechatronics - Specialization in Medical Technology, Optics, Optoelectronics · Timișoara, Romania
Certifications & licenses
Certification in Management and Business Administration
European Institut Eurocor
Certified Auditor
Similar Freelancers
Discover other experts with similar qualifications and experience
Cybersecurity Manager
Head of Quality Management and QM Taskforce
Head of Quality Assurance
Business Operations and ASPICE Quality Assurance
Quality Management Specialist
Quality Management Expert / Regulatory Affairs
Managing Director
Managing Director and Co-Founder
Quality Planning
Freelancer for Quality, Environmental and Occupational Safety Management
ISO 27001 Implementation
Consulting Engineer
Freelance QHSE Auditor
Quality Management Consultant
Business Owner
Site Manager Lithium-Ion Battery
Project Manager in Animal Husbandry and Feed
Founder and Senior Consultant
Interim Management - OPEX, BPM, LEAN CI, Quality
Interim - Support Customer Quality and Consultant for IATF 16949 audit
Consultant for the ISO 9001 Quality Management System
Sterbfritz Plant Technical Manager
Managing Director Management Consultant
Consultant/Coach ISO/SAE 21434 / UNECE R-155
Founder & Automotive Consultant
Senior Manager Quality Management
Interim Manager
Quality Manager QM - TÜV
Webinar Leader - Blackout Prevention and Preparation
