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Industrialization Engineer

JEFFERSON WELLS in CHARLEROI
time Online sinds 13 juli 2024 - Vaste jobs

Tender:

Participate if needed to technical clause to clause analysis during the tender phase for the industrial area in liaise with the Product Program Manager.

Concurrent Engineering:

  • Develop concurrent engineering and design to cost approach between development and industrialization Centers
  • Support product strategy and technology roadmap from industrial perspective
  • Apply Signalling Product Industrialization Process
  • Define Industrial Requirements specification per Product Line
  • Manage products Industrialization WP / provide prototypes needed
  • Define the most efficient industrial scheme (serial & repairs)
  • Take into account project requests from Project Industrial Manager: responsible for industrial and production work packages (QCD)
  • Contribute to reinforce relationship between Industrial and Signalling Engineering by participating to Product Program review

Industrialization:

  • Define the generic Product industrial breakdown structure (MBOM)
  • Manage industrial risk through Product / Process FMEA and associated improvement action plan when relevant
  • Support sourcing in the suppliers' qualification and quality follow up

Life Cycle:

  • Manage industrial Quality, Cost and Delivery of products during all life cycle and lead proper action plan (especially for recurring costs & Lead time optimization)
  • Ensure industrial sustainability of Product during life cycle: guarantee the manufacturability - reparability (incl.Test bench and parts obsolescence management / re-design proposal)
  • Improve Product competitiveness: cost optimization, lead time reduction, quality improvement
  • Provide and sustain Industrial maturity report per product line (definition files MR, test First Passed Yield per phase, failure rate at first installation, production cost, industrial scheme, lead time)
  • Manage traceability of product delivered to projects, and retrofit plan if needed
  • Manage the repair lead time and reduce the repair unitary cost
  • In case of non-conformity or incident, investigate root causes, finds and implement corrective solutions
  • Support Sourcing and Supplier Quality teams during quality crisis

Senior Quality Assurance Officer

SERB NV in ELSENE
time Online sinds 3 juli 2024 - Vaste jobs

QUALITY

  • Deputy Qualified Person for batch certification according to the Directive 2001/83/EC on medicinal products for human use and the guidelines on Good Manufacturing Practices (GMP) (Volume 4).
  • Deputy RP for Good Distribution Practices (GDP) according to the Directive 2001/83/EC on medicinal products for human use and the guidelines of 5 November 2013 on GDP for medicinal products for human use.
  • Review, compilation and release of batch records for administrative (GDP) release or batch certification (GMP), as appropriate.
  • Completion of register of released batches (and samples).
  • Quality oversight of contracted out manufacturing operations.
  • Assist in the management of the distribution including import and export of medicines.
  • Review and approval of transfer and validations of manufacturing and testing operations.
  • Lead the drafting/approval of product specifications.
  • Assist in the preparation of the quality management review at group level.
  • Proactively participate as a senior quality team member in the company's QMS processes, including but not limited to deviation/investigation management, corrective and preventative actions, change control and complaints management.
  • Ensure compliance with marketing authorisations / CE mark (regulatory dossier).
  • Assist in the management/coordination of all activities related to a batch recall
  • Proactively participate in the management of artwork and marketing/promotional materials.
  • Assist in the management of stability studies and Product Quality Review.
  • Ensure the compliant implementation of serialization.
  • Audits & Inspections:
    • Participate in the preparation and risk assessments for the internal and external audit schedules.
    • Plan and lead external audits.
    • Participate in inspections by competent authorities as a subject matter expert.
    • Participate in self-inspections / internal audits.

Other

  • Assist in local aspects of Regulatory Affairs
  • Assist the Medical and Vigilance (Pharmaco and Materiovigilance) department to ensure compliance at SERB SA.
  • Assist in the management of medical / scientific information requests.
  • Assist in the management of advertising, samples, compliance in relation to the RP function for Belgium, Luxembourg and the Netherlands.
  • Assist in the management of prices and refunds for Belgium, Luxembourg and the Netherlands.
  • Monitors the regulations in force and their evolution.
  • Assist for budget management.

Team management

  • This role does not have reporting staff, but is expected to work within the matrix of the local (SERB SA) and wider (SERB Pharmaceuticals) quality teams as a senior member.This will include providing support, training and mentoring to the more junior members of the team as required for team development and efficient and compliant performance of the team.

Senior Quality Assurance Officer

SERB NV in ELSENE
time Online sinds 3 juli 2024 - Vaste jobs

QUALITY

  • Deputy Qualified Person for batch certification according to the Directive 2001/83/EC on medicinal products for human use and the guidelines on Good Manufacturing Practices (GMP) (Volume 4).
  • Deputy RP for Good Distribution Practices (GDP) according to the Directive 2001/83/EC on medicinal products for human use and the guidelines of 5 November 2013 on GDP for medicinal products for human use.
  • Review, compilation and release of batch records for administrative (GDP) release or batch certification (GMP), as appropriate.
  • Completion of register of released batches (and samples).
  • Quality oversight of contracted out manufacturing operations.
  • Assist in the management of the distribution including import and export of medicines.
  • Review and approval of transfer and validations of manufacturing and testing operations.
  • Lead the drafting/approval of product specifications.
  • Assist in the preparation of the quality management review at group level.
  • Proactively participate as a senior quality team member in the company's QMS processes, including but not limited to deviation/investigation management, corrective and preventative actions, change control and complaints management.
  • Ensure compliance with marketing authorisations / CE mark (regulatory dossier).
  • Assist in the management/coordination of all activities related to a batch recall
  • Proactively participate in the management of artwork and marketing/promotional materials.
  • Assist in the management of stability studies and Product Quality Review.
  • Ensure the compliant implementation of serialization.
  • Audits & Inspections:
    • Participate in the preparation and risk assessments for the internal and external audit schedules.
    • Plan and lead external audits.
    • Participate in inspections by competent authorities as a subject matter expert.
    • Participate in self-inspections / internal audits.

Other

  • Assist in local aspects of Regulatory Affairs
  • Assist the Medical and Vigilance (Pharmaco and Materiovigilance) department to ensure compliance at SERB SA.
  • Assist in the management of medical / scientific information requests.
  • Assist in the management of advertising, samples, compliance in relation to the RP function for Belgium, Luxembourg and the Netherlands.
  • Assist in the management of prices and refunds for Belgium, Luxembourg and the Netherlands.
  • Monitors the regulations in force and their evolution.
  • Assist for budget management.

Team management

  • This role does not have reporting staff, but is expected to work within the matrix of the local (SERB SA) and wider (SERB Pharmaceuticals) quality teams as a senior member.This will include providing support, training and mentoring to the more junior members of the team as required for team development and efficient and compliant performance of the team.

Quality Engineer

CTRL-F in HERTSBERGE
time Online sinds 11 juni 2024 - Vaste jobs

As a Quality Engineer, you will analyse, develop, implement and maintain quality processes, installations and materials.

Throughout the process, you are in contact with colleagues as well as suppliers and subcontractors.

How does your responsibilities involve?

  • You analyse data and implement continuous improvement initiatives to improve product quality and reliability.
  • If production-related quality problems occur, you solve them: diagnoses root causes of system, process, equipment or material failures.
  • In cooperation with the required team, you determine which actions should be carried out.
  • You lead quality projects and are responsible for project follow-up, up to and including the final handover to the customer.
  • You lead the SPC project.
  • You optimize existing quality processes.
  • You evaluate and design test procedures, standards and inspection techniques.
  • You provide (technical) support and training to quality engineers, quality and production team leaders.
  • You work with suppliers to ensure the quality of incoming materials and components.
  • You prepare and follow up on quality audits.
  • You report to the Business Unit Manager.

Company:

Our client is part of an industrial holding company with several global market leaders under its wing.

Innovation is central here and this also ensures a strong position in the gear systems market, in particular.This combined with a team of passionate employees ensures a true partnership with their customers.

Their high-quality solutions are used in a wide range of applications and markets (e.g.compressors, motors, pumps, scanners, railways, agricultural and construction machinery.).

The main activities for their division in the Bruges region consist of small series of gears and on the other hand the machining of large series of prismatic parts and they are specialized in aluminium parts for 30 years.

Interested in joining the team?