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    Quality Engineer in Freiburg Germany - Regierungsbezirk Freiburg, Deutschland - Aloden Inc

    Aloden Inc
    Aloden Inc Regierungsbezirk Freiburg, Deutschland

    vor 1 Woche

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    Beschreibung

    Job Description:

    We are seeking a highly organized and detail-oriented Quality Management System (QMS) Coordinator to facilitate the alignment of Ormed site level QMS documentation with our Global QMS standards. In this role, you will conduct comprehensive assessments, identify necessary revisions, and coordinate the implementation of changes to ensure compliance and efficiency across the organization.

    Key Responsibilities:

    1. Conduct SIPOC Assessments: Perform thorough SIPOC assessments to compare Ormed site level QMS documentation with Our Global QMS documentation. Identify areas for improvement, gaps, and redundancies.

    2. Revision Identification: Determine and prioritize revisions required in Ormed site level QMS documentation to align with Our Global QMS standards. Collaborate with relevant stakeholders to implement necessary changes.

    3. Documentation Streamlining: Identify opportunities to streamline site level documentation by replacing it with Global level documentation where appropriate. Ensure consistency and coherence across all QMS documentation.

    4. Training Needs Analysis: Assess site level training needs related to QMS updates and changes. Develop and execute comprehensive training plans to ensure staff proficiency and compliance.

    5. Resource Coordination: Identify areas where additional resources or support from the Global Shared Services team or other Business Units are required for the successful execution of the Global QMS at the site level. Collaborate with stakeholders to secure necessary support.

    6. Change Control Management: Coordinate change controls in Agile methodology for the release of Ormed QMS process documentation and records. Ensure timely implementation of approved changes while maintaining documentation integrity.

    Qualifications and Skills:

    · Bachelor's degree in Quality Management, Business Administration, or a related field.

    · Proven experience in quality management systems, preferably in a regulated industry.

    · Strong understanding of SIPOC methodology and quality management principles.

    · Excellent analytical and problem-solving skills.

    · Proficiency in project management tools and methodologies, particularly Agile.

    · Effective communication and interpersonal skills for collaborating with cross-functional teams.

    · Attention to detail and ability to prioritize tasks in a fast-paced environment.

    · MDR and ISO13485

    · Certification in quality management (e.g., Six Sigma, ISO) is a plus.

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