Profil professionnel
Vue d'ensemble
Expérience
Formation
Compétences
Certificats
Informations complémentaires
Langues
Chronologie
Generic

Gaëlle LE LOC'H

Quality Manager
Valeyres s/s rances

Profil professionnel

Results driven R&D and Quality engineer with over 15 years in industries of food business and medical devices.

Strong expertise in problem solving and project managemet, I am collaborative and pragmatic to achieve results without compromising on safety, people, cost and compliance.


Vue d'ensemble

20
20
years of professional experience
6
6
years of post-secondary education
1
1
Certification

Expérience

QA Manager Investigation

MERZ AESTHETICS
01.2024 - 04.2025
  • Process Owner for Non conformity, CAPA and Quality Metrics process for Medical Devices Class III.
  • Definition of KPI's and reporting to leadership team.
  • Lead Investigations - Root cause analysis, 8D methodology, 5W/6M, Fishbone
  • Management of 5 direct reports. Coordination of the team's day-to-day activities.
  • Support and Coach people in their investigation for all departments
  • Managing budgets, monitoring expenditure and recommending adjustments.

Site Quality Assurance Supervisor

DENTSPLY SIRONA
Ballaigues
02.2020 - 12.2023
  • Process Owner for Process Validation, Metrology, Non-Conformities & Process Change Control for Ballaigues site – manufacturing site of medical devices Class I and IIa (~750 employees).
  • Team management with 13 direct reports (Technicians & Engineers), recruitment of 5 engineers or technicians.
  • Coach and train on problem solving with tools as 5W or 6M
  • Audits: Front lead BSI Audit, Internal auditor, GMP auditor, in charge of Microbiological audits with notify bodies (BSI).

QUALITY Development Supervisor

DENTSPLY SIRONA
10.2017 - 02.2020
  • Lead of Quality Customer partnership for medical device Class IIa
  • Lead Customer Audits (at least 5 per year)
  • Lead Process Validation projects for new products, identify and complete NC/CAPA and run Change Controls
  • Lead of Quality design of Product development.
  • PPAP dossier and perform FAI (first article inspection) : Perform Risk analysis, Capabilities & analytical method R&R according to customer needs
  • Run Line operational Quality (KPIs/Projects) with 2 direct reports
  • Support customer in MDR remediation
  • Collaboration with R&D, Sales, Industrialization teams.

R&D Lean Office Pillar Leader

NESTLE
12.2016 - 09.2017
  • Development of Lean Mindset in R&D, through the implementation of BPM (Business Process Management) for all Nestlé R&D sites worldwide in order to standardize, simplify and share best practices.
  • Coaching of R&D site referents to develop their LEAN skills/experiences, and their communication tools (Visual A3, Sharepoint, Intranet).

Pilot Plant Manager & FI Pilar Lead

CPW Cereal Partners Worldwide (Nestlé & General Mills)
09.2014 - 12.2016
  • Team Management of Pilot plant Operations technicians, including logistics and raw material maangement (13 technicians)


  • Lead Project : Improvement of R&D quality runs by 20% on the Cereals process, set up an organization allowing greater flexibility and enhanced prototyping for innovation.


  • Nestlé Coach for DMAIC, SMED & Risk Management projects (PFMEA). Lead Problem Solving pillar

R&D Project Manager

CPW Cereal Partners Worldwide (Nestlé & General Mills)
01.2011 - 09.2014
  • Lead Project: Development & Industrialization of new fortified cereals in 5 European plants. Improvement of process capability by 30%, enabling each plant to achieve Recipe nutritional compliance, and a cost reduction of 500kCHF.
  • Analytical coordinator for all CPW R&D projects, working closely with Nestlé & GMI analytical experts.
  • Active member of the Statistics in Practice network at Nestlé.

R&D Quality Engineer

CPW Cereal Partners Worldwide (Nestlé & General Mills)
09.2008 - 01.2011
  • Management of Quality engineering projects to improve Quality performance of lines on key regulated ingredients (Vitamins, Sugar).
  • Provide support to project managers to analyse data and perform statistical analysis for problem solving.

Factory QA Engineer

CPF Itancourt - Nestlé
Itancourt
02.2005 - 08.2006
  • Lead Quality Process projects to improve Line performance in Itancourt Factory
  • Product release for extrusion line
  • Supervision of Analytical laboratory, and sensory testing

Formation

MASTER FOOD BUSINESS & STATISTICS - Food Business & Statistics

AgroCampus Ouest
Rennes
01.2001 - 01.2005

BACHELOR - Microbiology, Nutrition, Process

TECHNICAL UNIVERSITY
01.1999 - 01.2001

Compétences

  • CAPA / Non Conformance: Root Cause Analysis, Corrective actions, Verification of effectiveness, DMAIC, 8D methodology
  • Quality processes: Change Control, Risk Assessment - FMEA, Internal Audits
  • Regulatory Compliance: ISO 13485, MDR, MDSAP, CFR Part 820
  • Technical tools & Software : MasterControl, Smartsolve, JIRA, SAP, AXDynamics, Minitab, Pack Office
  • Communication : Power Point, Minutes of meetings, feedback, Coaching
  • Collaborative, and results focus

Certificats

  • Green Belt Certification, 2013-12-01
  • Black Belt trained

Informations complémentaires

  • Sports: Cross-country skiing, Running, Cycling and Hiking
  • Association committee member of Passeport Vacances Orbe
  • Association committee member of Course des Renards - Valyres sous Rances

Langues

French
Bilingue
English
Courant
Spanish
Opérationnel

Chronologie

QA Manager Investigation

MERZ AESTHETICS
01.2024 - 04.2025

Site Quality Assurance Supervisor

DENTSPLY SIRONA
02.2020 - 12.2023

QUALITY Development Supervisor

DENTSPLY SIRONA
10.2017 - 02.2020

R&D Lean Office Pillar Leader

NESTLE
12.2016 - 09.2017

Pilot Plant Manager & FI Pilar Lead

CPW Cereal Partners Worldwide (Nestlé & General Mills)
09.2014 - 12.2016

R&D Project Manager

CPW Cereal Partners Worldwide (Nestlé & General Mills)
01.2011 - 09.2014

R&D Quality Engineer

CPW Cereal Partners Worldwide (Nestlé & General Mills)
09.2008 - 01.2011

Factory QA Engineer

CPF Itancourt - Nestlé
02.2005 - 08.2006

MASTER FOOD BUSINESS & STATISTICS - Food Business & Statistics

AgroCampus Ouest
01.2001 - 01.2005

BACHELOR - Microbiology, Nutrition, Process

TECHNICAL UNIVERSITY
01.1999 - 01.2001
Gaëlle LE LOC'HQuality Manager