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Quality Systems Analyst

Eingestellt von Elevate Direct

Projektbeschreibung

QUALITY SYSTEMS ANALYST - LEIDEN - NETHERLANDS - €34 - €36 PER HOUR - 4 MONTHS

The Quality Systems Analyst (Change Control) is the Change Analyst for Document Control and Change Control. The Quality Systems Analyst ensures the continuous education, implementation and improvement of Quality Systems and compliance with QS Regulation and ISO within the Leiden facility. The Quality Systems Analyst ensures that the Leiden Plant, Document Control and Change Control Processes and structure meet all business and regulatory requirements. Responsible for Site Records Management and Site Record Management representative for Mentor Leiden.

PRINCIPLE DUTIES AND RESPONSIBILITIES

Ensures quality systems are effectively deployed.

Performs periodic checks to verify appropriate application.

Maintain regular interface with Management

Uses statistical methods, quality tools and computer generated reports to continuously improve process capability

Provide education/training as needed regarding Document Control and Change Control processes including MVI/Validation Documents.

Leads and participates in quality system improvement initiatives.

Conducts internal audits to determine compliance with quality management system standards as well as regulatory and customer requirements.

Determines root causes of quality issues and develops corrective actions and recommendations.

Suggests process changes when appropriate.

Establishes, maintains and implements communications to increase awareness and promote improvement of quality issues across the business.

Assists department head in implementing new product development procedures and documentation.

Assists with external audits, generating reports with corrective action plans and ensuring implementation of corrective actions in a timely manner.

Responsible for the Site Records Management being the Site Record Management representative:

REQUIRED EDUCATION AND KNOWLEDGE

University/Bachelor's Degree or Equivalent

Lean/Six Sigma Green Belt is desired for this position, with a background in Statistics.

Able to communicate and writing skills in English

Mathematical and analytical thinking skills

Related relevant experience. Medical device manufacturing experience preferred.

Experience with audits preferred (Notified bodies and/or Competent Authorities).

Ability to write reports, business correspondence, procedure manuals and related documentation that conform to prescribed style and format.

Ability to effectively present information and respond to questions from groups of managers, clients, and customers.

ADDITIONAL INFORMATION ABOUT THE PROCESS

Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.

This job with Johnson & Johnson is a temporary assignment and is being managed by Kelly Services on behalf of Johnson & Johnson. Successful candidates will be placed at the Johnson & Johnson assignment and managed by Kelly Services

If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly.

Projektdetails

  • Einsatzort:

    Leiden, Niederlande

  • Projektbeginn:

    asap

  • Projektdauer:

    4 months

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Sonstiges

Elevate Direct