Medical Device Technical Project Leader Labeling/Packaging – Development - Olten, Schweiz - Gerresheimer

    Gerresheimer
    Gerresheimer Olten, Schweiz

    vor 3 Wochen

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    Ganztags
    Beschreibung

    Job Description

  • Improve continuously the Labeling and Packaging Process for which you are the owner and manage the interface to the stakeholders of the related disciplines.
  • Lead and coordinate cross-functional project teams consisting of engineers, designers, regulatory experts, quality assurance specialists, and manufacturing personnel.
  • Develop project plans, timelines, and budgets, and ensure adherence to project milestones and deadlines.
  • Collaborate with stakeholders to define project scope, objectives, and requirements.
  • Conduct risk assessments and implement mitigation strategies to ensure project success.
  • Manage the design, development, transfer into production, testing, and validation of labeling and packaging solutions for medical devices.
  • Ensure compliance with regulatory requirements, including FDA regulations, ISO 11607 standards, and other relevant guidelines.
  • Drive continuous improvement initiatives to enhance efficiency, quality, and cost-effectiveness of labeling and packaging processes.
  • Provide regular project updates to senior management and stakeholders, highlighting progress, challenges, and recommendations for course correction.
  • Foster a culture of collaboration, innovation, and accountability within the project team.

    • Qualifications

  • Bachelor's degree in engineering, packaging science, or a related field; advanced degree preferred.
  • Minimum of 5 years of experience in project management, with a focus on labeling and packaging in the medical device industry.
  • Proven track record of successfully leading complex projects from initiation to completion, on time and within budget.
  • Strong understanding of regulatory requirements for labeling and packaging of medical devices, including FDA regulations and ISO standards.
  • Excellent communication, leadership, and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
  • Demonstrated problem-solving abilities and a proactive approach to identifying and resolving issues.
  • Experience with project management tools and methodologies (e.g., Agile, Scrum, Six Sigma) preferred.
  • PMP certification or equivalent is a plus.