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
2024.01 - 2025.04
- 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
2020.02 - 2023.12
- 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
2017.10 - 2020.02
- 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
2016.12 - 2017.09
- 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)
2014.09 - 2016.12
- 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)
2011.01 - 2014.09
- 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)
2008.09 - 2011.01
- 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
2005.02 - 2006.08
- 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 2001.01 - 2005.01
BACHELOR - Microbiology, Nutrition, Process
TECHNICAL UNIVERSITY
1999.01 - 2001.01
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
2024.01 - 2025.04
Site Quality Assurance Supervisor
DENTSPLY SIRONA
2020.02 - 2023.12
QUALITY Development Supervisor
DENTSPLY SIRONA
2017.10 - 2020.02
R&D Lean Office Pillar Leader
NESTLE
2016.12 - 2017.09
Pilot Plant Manager & FI Pilar Lead
CPW Cereal Partners Worldwide (Nestlé & General Mills)
2014.09 - 2016.12
R&D Project Manager
CPW Cereal Partners Worldwide (Nestlé & General Mills)
2011.01 - 2014.09
R&D Quality Engineer
CPW Cereal Partners Worldwide (Nestlé & General Mills)
2008.09 - 2011.01
Factory QA Engineer
CPF Itancourt - Nestlé
2005.02 - 2006.08
MASTER FOOD BUSINESS & STATISTICS - Food Business & Statistics
AgroCampus Ouest
2001.01 - 2005.01
BACHELOR - Microbiology, Nutrition, Process
TECHNICAL UNIVERSITY
1999.01 - 2001.01