Quality Efficiency Manager
Sartorius
Aubagne
il y a 2j

AIM OF THE MISSION Continuous improvement of BPS core processes, ensure methodology standards in projects and Operations (quality basics in production and in development), training in methodologies, 6 Sigma and problem solving (e.

g. QRQC, 8D and quick fix), global strategic operational projects and methodology support / coaching / mentoring across the organization.

SITUATION IN THE ORGANIZATION Reports to the Head of Quality Management BPSMAIN TASKS / TECHNICAL NATURE OF JOB - Lead and coordinate global BPS continuous improvement projects e.

g. scrap reduction, particle reduction- Lead and coordinate global initiatives for continuous improvement, harmonization and simplification of BPS core processes e.

g. complaint improvement management, CAPA improvement management- Define, improve and train standards and methodologies in PMO e.

g. product and process qualification strategies, 8D, design efficiency basics, quality efficiency basics in production, FMEA.

  • Operational scope : single-use consumables- Oversee, coach and guide the right execution of tools and standards in PMO & maintenance projects qualifications, FMEAs, capabilities, MSA, critical attributes, control plan.
  • Support local continuous improvement initiatives with guidance and / or resources- Standardize and transversalize best practices in BPS Sites- Deploy FMEA, Statistics, Quality basics in development and production and Problem Solving methodologies training programs at management, basic, intermediate and referent / advanced levels- Train global and local teams across all departments on problem solving methodologies (8D, quick fix) and variability reduction (6 Sigma, DMAIC)- Train and coach Green Belts and Black Belts- Train Yellow Belts- Manage resources- Participate actively to definition and improvement of FMT standards and tools- Build a community of methodology referents and experts within BPSCOMMUNICATION / TREATMENT OF INFORMATION - Interactions with Product Development, Supply Chain, Production, Supplier Quality, Sourcing, QA / QC, EHS, Continuous Improvement & Technologies, Local Continuous Improvement, Local Quality, Quality Services, Sales, Marketing, Quality Systems, Regulatory Affairs- Key Account Customers and main Suppliers where required- Regular communication with the management reporting status and performance- Plants : BPS SitesAUTONOMY / RESPONSABILITY - Organize & execute work in respect with GMP, GxP, regulations, standards and ISO 9001.
  • Works by missions or projects determined by Direction according to the rules and processes defined by his / her direct management- Must solve complex issues requiring a preliminary analysis and relevant action items.
  • CROSS-FUNCTIONAL / SUPERVISION 1. Cross-functional responsibility : train and coach methodologies for BPS core processes - e.

    g. problem solving, quality basics in production, FMEA, process / product variability...2. Hierarchical responsibility : hierarchical management of people (FMEA Expert)CONTRIBUTION QUALITY, HYGIENE, SAFETY AND ENVIRONNEMENT The job holder contributes to the respect of quality, hygiene, safety and environment rules, by respecting quality, hygiene, safety and environment instructions and detecting potential quality anomalies and incidents or safety environment risks of accident and informing his / her manager or the department in charge to manage them.

    KNOWLEDGE REQUIRED - Engineer / master degree in engineering or biotechnology- 6 Sigma Black Belt or Master Black Belt focus on variability reduction- Soft skills : facilitation, moderation, teaching, empathy, assertiveness, objective & solution-oriented, team work, data driven & analytical, open-minded, transparency & communication- English fluent mandatory- Strong risk assessment knowledge- Strong problem solving methodologies knowledge e.

    g. QRQC- GMP knowledge or Medical device knowledge / ISO13485 is a plus

    aim of the mission

    Continuous improvement of BPS core processes, ensure methodology standards in projects and Operations (quality basics in production and in development), training in methodologies, 6 Sigma and problem solving (e.

    g. QRQC, 8D and quick fix), global strategic operational projects and methodology support / coaching / mentoring across the organization.

    Situation in the organization

    Reports to the Head of Quality Management BPS

    Main tasks / Technical nature of job

  • Lead and coordinate global BPS continuous improvement projects e.g. scrap reduction, particle reduction
  • Lead and coordinate global initiatives for continuous improvement, harmonization and simplification of BPS core processes e.
  • g. complaint improvement management, CAPA improvement management

  • Define, improve and train standards and methodologies in PMO e.g. product and process qualification strategies, 8D, design efficiency basics, quality efficiency basics in production, FMEA...
  • Operational scope : single-use consumables

  • Oversee, coach and guide the right execution of tools and standards in PMO & maintenance projects qualifications, FMEAs, capabilities, MSA, critical attributes, control plan...
  • Support local continuous improvement initiatives with guidance and / or resources
  • Standardize and transversalize best practices in BPS Sites
  • Deploy FMEA, Statistics, Quality basics in development and production and Problem Solving methodologies training programs at management, basic, intermediate and referent / advanced levels
  • Train global and local teams across all departments on problem solving methodologies (8D, quick fix) and variability reduction (6 Sigma, DMAIC)
  • Train and coach Green Belts and Black Belts
  • Train Yellow Belts
  • Manage resources
  • Participate actively to definition and improvement of FMT standards and tools
  • Build a community of methodology referents and experts within BPS
  • Communication / Treatment of information

  • Interactions with Product Development, Supply Chain, Production, Supplier Quality, Sourcing, QA / QC, EHS, Continuous Improvement & Technologies, Local Continuous Improvement, Local Quality, Quality Services, Sales, Marketing, Quality Systems, Regulatory Affairs
  • Key Account Customers and main Suppliers where required
  • Regular communication with the management reporting status and performance
  • Plants : BPS Sites
  • Autonomy / Responsability

  • Organize & execute work in respect with GMP, GxP, regulations, standards and ISO 9001.
  • Works by missions or projects determined by Direction according to the rules and processes defined by his / her direct management
  • Must solve complex issues requiring a preliminary analysis and relevant action items.
  • Cross-functional / Supervision

    Cross-functional responsibility : train and coach methodologies for BPS core processes - e.g. problem solving, quality basics in production, FMEA, process / product variability...

    Hierarchical responsibility : hierarchical management of people (FMEA Expert)

    Contribution Quality, Hygiene, Safety and Environnement

    The job holder contributes to the respect of quality, hygiene, safety and environment rules, by respecting quality, hygiene, safety and environment instructions and detecting potential quality anomalies and incidents or safety environment risks of accident and informing his / her manager or the department in charge to manage them.

    Knowledge REQUIRED

  • Engineer / master degree in engineering or biotechnology
  • 6 Sigma Black Belt or Master Black Belt focus on variability reduction
  • Soft skills : facilitation, moderation, teaching, empathy, assertiveness, objective & solution-oriented, team work, data driven & analytical, open-minded, transparency & communication
  • English fluent mandatory
  • Strong risk assessment knowledge
  • Strong problem solving methodologies knowledge e.g. QRQC
  • GMP knowledge or Medical device knowledge / ISO13485 is a plus
  • Interested? Driving our future growth requires talented people. Sartorius is a dynamic organisation suited to people who want to showcase skills, be recognised for expertise and thrive in a vibrant and innovative environment.

    Become part of our global team.

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