Quality Assurance Engineer - EIMEA
Accuray
Morges, Vaud, Switzerland
vor 4 Std.

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Job Description

POSITION TITLE : QUALITY ASSURANCE ENGINEER EIMEA

SUMMARY :

The Quality Engineer will represent Quality Assurance on Projects Planning, Installations, Service as well as Processes for suppliers’ control in EIMEA region.

Partners with internal departments to assure that Quality Management System (QMS) is in line with Accuray’s policies, procedures and regulatory standards such as ISO 13485, 21 CFR Part 820, 93 / 42 / EEC and 2017 / 745 / EC.

Leads continuous improvement of the Quality System.

This role will be based in our International HQ located in Morges, Switzerland.

REPORTING TO / DEPARTMENT :

Reports to Director Customer Care EIMEA with a dotted line to Director of Quality Assurance Global

ESSENTIAL DUTIES AND RESPONSIBILITIES :

  • Develop, revise and manage policies and procedures for Supplier (including Accuray distributors) management including qualification process, quality audits, supplier training, supplier documentation review
  • Administrate and execute tools calibration program.
  • Support customer and internal complaints investigation, monitor corrective actions documentation and execution. Participates in Risk Analysis as appropriate.
  • Support internal Quality system audits.
  • Provide quality trainings to Operations teams with a focus on case studies.
  • Provide QA review of Service, Site Planning, Installation and Acceptance documents.
  • Support investigations with HQ quality teams for material issue resolution.
  • Assists in development of QA SOPs and Work Instructions which ensure validity, adequacy, and compliance to regulatory and corporate requirements;
  • provide innovative solutions to minimize costs.

  • Assist with the management and continuous improvement of the Quality Management System, including development of meaningful metrics to measure the effectiveness of the quality systems.
  • The incumbent may be asked to perform other function-related activities in addition to the above-mentioned responsibilities as reasonably required by business needs.

    REQUIRED QUALIFICATIONS :

    Required :

  • Bachelor of Science degree in Engineering or equivalent, or equivalent work experience.
  • 2+ years’ industry experience in the areas of Quality Assurance, experience in the medical device or in related area.
  • Competency in the FDA Medical Device Quality System Regulation or ISO 9000.
  • Must be fluent in English.
  • Oral and written communication skills and effective interpersonal skills and proven technical writing experience in the medical device industry.
  • Proven ability to make improvements in processes and systems in a Quality Systems environment.
  • Organizational skills and Customer Service oriented person.
  • Experience in the use of PC’s and typical software applications including Word, Excel, Outlook, database packages and other as well as experience in ERP Systems is desired.
  • An ability to travel is required. Personnel can expect approximately 25% travel time.
  • Preferred or Desired :

  • Additional European language is a plus in particular French and German.
  • Proven ability to make improvements in processes and systems in a Quality Systems environment.
  • Engineering background relevant to medical devices.
  • Ability to comprehend principles of engineering and medical device use is a plus

    To qualify for this position, candidates must be able to furnish proof that they are authorized to work in the country they are applying on a permanent basis without sponsorship.

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