Senior Quality Engineering professional with 8+ years of international experience across automotive, electronics, battery and manufacturing industries
Aktualisiert am 14.04.2026
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 14.04.2026
Verfügbar zu: 100%
davon vor Ort: 100%
PFMEA
DFMEA
Control Plans
SPC
MSA
8D
5-Why
Ishikawa
QRQC
Six Sigma Green Belt
IATF 16949
VDA 6.3
ISO 9001
ISO 13485
ISO 14971
SAP QM
Supplier Audits
Internal Audits
Process Audits
Product Audits
English
C1 - business fluent
German
B1 - Intermediate
Hindi
C1 - business fluent

Einsatzorte

Einsatzorte

Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

6 months
2024-11 - 2025-04

Quality Engineering

Senior Quality Engineer
Senior Quality Engineer
  • Acted as interface between production, engineering and customers for all quality topics ? central contact for complaints, deviations and quality clarifications; resolved 1,000+ NCRs achieving a 60% defect reduction
  • Supported the shopfloor in analysing and resolving quality problems ? applied 8D, Ishikawa & 5-Why; implemented corrective actions and verified effectiveness with shopfloor presence
  • Processed customer complaints, changes and deviations ? managed end-to-end complaint handling; assessed deviations; initiated and coordinated corrective & sorting measures
  • Contributed to process optimisations and continuous improvement ? applied Six Sigma DMAIC and Lean methodology; drove quality improvements across manufacturing and supply chain processes
  • Supported validation and testing activities in production ? reviewed and approved validation documentation; assessed test deviations; ensured compliance with ISO 13485 and 21 CFR Part 820
  • Participated in internal, customer and supplier audits; ensured compliance with quality and regulatory requirements ? ISO 13485, EU MDR and 21 CFR Part 820; maintained QMS documentation and quality manual
Livanova Deutschland GmbH, Germany
6 months
2023-12 - 2024-05

Quality Engineering

Quality Engineer
Quality Engineer
  • Processed customer complaints, changes and deviations in SAP QM ? root cause analysis using 8D, 5-Why & Ishikawa; implemented corrective actions and verified effectiveness
  • Contributed to process optimisation and continuous improvement ? assessed deviations; initiated sorting, blocking or return of non-conforming parts; monitored supplier KPIs and quality scorecards
  • Participated in customer audits; supported shopfloor quality activities; enforced Customer Specific Requirements and maintained zero uncontrolled process changes via PCN tracking
  • Ensured compliance with quality and regulatory requirements ? developed & maintained ISO 9001/ IATF 16949 procedures, work instructions and quality documentation
IRISO Electronics Europe GmbH, Germany
2 years
2021-11 - 2023-10

SOP planning including APQP, PPAP, process validation and quality release

Quality Engineer & Industrialisation
Quality Engineer & Industrialisation
  • Executed full greenfield product transfer of JV battery pack line to Turkey ? scoping to SOP including APQP, PPAP, process validation & quality sign-off
  • Developed & maintained process documentation in PLM ? PFMEA, Control Plans, inspection planning, process flow diagrams & visual aids
  • Verified & validated production lines; managed requalification for series production transfers & rolled out CTQ controls across production lines
  • Supported DFMEA & DFMA reviews with Design and Test Engineers; developed quality standards & manufacturing requirements aligned to customer expectations
Farasis Energy Europe, Germany
4 years 2 months
2015-08 - 2019-09

Quality & Manufacturing Engineering

Specialist, Quality & Manufacturing Engineering
Specialist, Quality & Manufacturing Engineering
  • Commissioned Industry 4.0 inspection area ? reduced inspection time by 60%; awarded Best Kaizen 2017 & Best Innovation 2018
  • Led new product introduction from concept to SOP ? PFMEA, MSA, control plans, equipment & process validation; owned full CAPA lifecycle using 8D, corrective action implementation & effectiveness verification
  • Implemented SPC for critical features to control, monitor & improve process performance; managed customer complaints end-to-end via 8D methodology
  • Analysed MIM feasibility from customer drawings; supported new product development & preparation of prototypes and test procedures
INDO MIM Pvt. Ltd., India

Aus- und Weiterbildung

Aus- und Weiterbildung

2022
M.Eng. Automotive Production Engineering
Technical University of Ingolstadt (Germany)

2015
B.Eng. Industrial & Production Engineering
SJCE, India

CERTIFICATIONS & TRAINING
  • Six Sigma Green Belt ? Qual Mind Global, India (2019)
  • Lean Management Training ? M. Arnd Kaiser, Europe (2020)
  • Leadership & Shopfloor Management ? AUDI AG, Ingolstadt (2021)

Position

Position

Quality Engineer | Medical Devices · ISO 13485 · 21 CFR Part 820 · Complaints

Kompetenzen

Kompetenzen

Top-Skills

PFMEA DFMEA Control Plans SPC MSA 8D 5-Why Ishikawa QRQC Six Sigma Green Belt IATF 16949 VDA 6.3 ISO 9001 ISO 13485 ISO 14971 SAP QM Supplier Audits Internal Audits Process Audits Product Audits

Produkte / Standards / Erfahrungen / Methoden

Profile
Quality Engineering professional with 8+ years of international experience across medical devices, automotive, electronics, battery and metal injection molding (MIM) industries. Proven as interface between production, engineering and customers for all quality topics ? supporting shopfloor quality, processing customer complaints, deviations and changes, contributing to process optimisations and continuous improvement, supporting validation and testing activities, participating in internal/customer/supplier audits, and ensuring compliance with ISO 13485 and 21 CFR Part 820. Hands-on mentality with strong shopfloor presence. Experienced in plastic injection moulding quality at INDO MIM. Resolved 1,000+ NCRs with a 60% defect reduction. Hands-on with SAP QM, IATF 16949, VDA 6.3, PFMEA, SPC, MSA, and 8D. Six Sigma Green Belt. English C1, German B1.

TECHNICAL SKILLS
  • QM Standards: ISO 13485, 21 CFR Part 820, EU MDR, ISO 9001, IATF 16949, VDA 6.3, ISO 14971
  • Medical Device QE: Shopfloor Quality, Customer Complaints, Validation Support, CAPA, Audits
  • Core Tools: PFMEA, DFMEA, Control Plans, SPC, MSA, 8D, 5-Why, Ishikawa, QRQC
  • Audits: Supplier Audits, Internal Audits, Process Audits, Product Audits (IATF 16949, VDA 6.3)
  • Software: SAP QM, MS Office 365, Agile Works, Siemens NX, CATIA, SolidWorks
  • Lean/ CI: Six Sigma Green Belt, Lean Management, Kaizen, Industry 4.0

CAREER SUCCESSES
  • Established JV battery pack & module production line in Turkey ? full scoping to SOP (2021?2023)
  • Best Innovation Award ? integrated 3-to-1 inspection gauge for turbocharger vane, reducing inspection time by 60% (2018)
  • Best Kaizen Award ? eliminated turbocharger vane mix-up at inspection area (2017)
  • Highest Cost Saving Award ? implemented Lean & Six Sigma DMAIC achieving 50% FPY improvement for HILTI parts (2016)

Einsatzorte

Einsatzorte

Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

6 months
2024-11 - 2025-04

Quality Engineering

Senior Quality Engineer
Senior Quality Engineer
  • Acted as interface between production, engineering and customers for all quality topics ? central contact for complaints, deviations and quality clarifications; resolved 1,000+ NCRs achieving a 60% defect reduction
  • Supported the shopfloor in analysing and resolving quality problems ? applied 8D, Ishikawa & 5-Why; implemented corrective actions and verified effectiveness with shopfloor presence
  • Processed customer complaints, changes and deviations ? managed end-to-end complaint handling; assessed deviations; initiated and coordinated corrective & sorting measures
  • Contributed to process optimisations and continuous improvement ? applied Six Sigma DMAIC and Lean methodology; drove quality improvements across manufacturing and supply chain processes
  • Supported validation and testing activities in production ? reviewed and approved validation documentation; assessed test deviations; ensured compliance with ISO 13485 and 21 CFR Part 820
  • Participated in internal, customer and supplier audits; ensured compliance with quality and regulatory requirements ? ISO 13485, EU MDR and 21 CFR Part 820; maintained QMS documentation and quality manual
Livanova Deutschland GmbH, Germany
6 months
2023-12 - 2024-05

Quality Engineering

Quality Engineer
Quality Engineer
  • Processed customer complaints, changes and deviations in SAP QM ? root cause analysis using 8D, 5-Why & Ishikawa; implemented corrective actions and verified effectiveness
  • Contributed to process optimisation and continuous improvement ? assessed deviations; initiated sorting, blocking or return of non-conforming parts; monitored supplier KPIs and quality scorecards
  • Participated in customer audits; supported shopfloor quality activities; enforced Customer Specific Requirements and maintained zero uncontrolled process changes via PCN tracking
  • Ensured compliance with quality and regulatory requirements ? developed & maintained ISO 9001/ IATF 16949 procedures, work instructions and quality documentation
IRISO Electronics Europe GmbH, Germany
2 years
2021-11 - 2023-10

SOP planning including APQP, PPAP, process validation and quality release

Quality Engineer & Industrialisation
Quality Engineer & Industrialisation
  • Executed full greenfield product transfer of JV battery pack line to Turkey ? scoping to SOP including APQP, PPAP, process validation & quality sign-off
  • Developed & maintained process documentation in PLM ? PFMEA, Control Plans, inspection planning, process flow diagrams & visual aids
  • Verified & validated production lines; managed requalification for series production transfers & rolled out CTQ controls across production lines
  • Supported DFMEA & DFMA reviews with Design and Test Engineers; developed quality standards & manufacturing requirements aligned to customer expectations
Farasis Energy Europe, Germany
4 years 2 months
2015-08 - 2019-09

Quality & Manufacturing Engineering

Specialist, Quality & Manufacturing Engineering
Specialist, Quality & Manufacturing Engineering
  • Commissioned Industry 4.0 inspection area ? reduced inspection time by 60%; awarded Best Kaizen 2017 & Best Innovation 2018
  • Led new product introduction from concept to SOP ? PFMEA, MSA, control plans, equipment & process validation; owned full CAPA lifecycle using 8D, corrective action implementation & effectiveness verification
  • Implemented SPC for critical features to control, monitor & improve process performance; managed customer complaints end-to-end via 8D methodology
  • Analysed MIM feasibility from customer drawings; supported new product development & preparation of prototypes and test procedures
INDO MIM Pvt. Ltd., India

Aus- und Weiterbildung

Aus- und Weiterbildung

2022
M.Eng. Automotive Production Engineering
Technical University of Ingolstadt (Germany)

2015
B.Eng. Industrial & Production Engineering
SJCE, India

CERTIFICATIONS & TRAINING
  • Six Sigma Green Belt ? Qual Mind Global, India (2019)
  • Lean Management Training ? M. Arnd Kaiser, Europe (2020)
  • Leadership & Shopfloor Management ? AUDI AG, Ingolstadt (2021)

Position

Position

Quality Engineer | Medical Devices · ISO 13485 · 21 CFR Part 820 · Complaints

Kompetenzen

Kompetenzen

Top-Skills

PFMEA DFMEA Control Plans SPC MSA 8D 5-Why Ishikawa QRQC Six Sigma Green Belt IATF 16949 VDA 6.3 ISO 9001 ISO 13485 ISO 14971 SAP QM Supplier Audits Internal Audits Process Audits Product Audits

Produkte / Standards / Erfahrungen / Methoden

Profile
Quality Engineering professional with 8+ years of international experience across medical devices, automotive, electronics, battery and metal injection molding (MIM) industries. Proven as interface between production, engineering and customers for all quality topics ? supporting shopfloor quality, processing customer complaints, deviations and changes, contributing to process optimisations and continuous improvement, supporting validation and testing activities, participating in internal/customer/supplier audits, and ensuring compliance with ISO 13485 and 21 CFR Part 820. Hands-on mentality with strong shopfloor presence. Experienced in plastic injection moulding quality at INDO MIM. Resolved 1,000+ NCRs with a 60% defect reduction. Hands-on with SAP QM, IATF 16949, VDA 6.3, PFMEA, SPC, MSA, and 8D. Six Sigma Green Belt. English C1, German B1.

TECHNICAL SKILLS
  • QM Standards: ISO 13485, 21 CFR Part 820, EU MDR, ISO 9001, IATF 16949, VDA 6.3, ISO 14971
  • Medical Device QE: Shopfloor Quality, Customer Complaints, Validation Support, CAPA, Audits
  • Core Tools: PFMEA, DFMEA, Control Plans, SPC, MSA, 8D, 5-Why, Ishikawa, QRQC
  • Audits: Supplier Audits, Internal Audits, Process Audits, Product Audits (IATF 16949, VDA 6.3)
  • Software: SAP QM, MS Office 365, Agile Works, Siemens NX, CATIA, SolidWorks
  • Lean/ CI: Six Sigma Green Belt, Lean Management, Kaizen, Industry 4.0

CAREER SUCCESSES
  • Established JV battery pack & module production line in Turkey ? full scoping to SOP (2021?2023)
  • Best Innovation Award ? integrated 3-to-1 inspection gauge for turbocharger vane, reducing inspection time by 60% (2018)
  • Best Kaizen Award ? eliminated turbocharger vane mix-up at inspection area (2017)
  • Highest Cost Saving Award ? implemented Lean & Six Sigma DMAIC achieving 50% FPY improvement for HILTI parts (2016)

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