Quality Manager
Spectracure AB / Kemiingenjörsjobb / Lund
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Position: Quality Manager
Experience and personal profile
Experience in QA management work in the medical device area, and particularly ISO 13485, is a requirement. Self-going and takes the proper initiatives to ensure that the quality management system is maintained, that all internal and external quality audits are handled as required, and that contacts with regulatory authorities and notified body are maintained. Reports to CEO and works in collaboration with other key functions at the company. Collaborates in particular with the design and development team to support maintenance of the product technical file.
Fluent in spoken and written English.
Responsibilities and Duties
• Maintain the quality management system
• Collect and compile data and information related to the quality management system
• Initiate improvements and changes to SpectraCure routines
• Appointed management representative according to ISO 13485
• Surveillance of new or revised regulatory requirements
• Responsible for relations with external parties such as notified body, regulatory authority and or consultants to the quality management system
• Plan, perform and report internal audits
• Act as project manager when appointed
• Participate as quality representative in development projects
• Review and approve documentation within area of responsibility
• Compile and archive quality documents and product documentation
• Compile and submit product applications to notified body and regulatory authorities
• Carry out subcontractor (supplier and consultant) quality audits
• Prepare and review release documentation for SpectraCure products
• Review and evaluate information regarding quality, reliability and safety of devices
• Coordinate complaints work
• Order material and services on request
• Identify training needs within area of responsibility
• Participate in training according to individual training plan
• Follow procedures established in the SpectraCure Quality Management System as well as laws and regulations
Authority
• Provide quality system training for SpectraCure's personnel
• Report to top management on the performance of the quality management system and any need for improvement
• To act as project manager when appointed
• Review and approve documentation within area of responsibility
• Approve or change procedures within area of responsibility
• Approve or disapprove subcontractors
• Initiate contact with and maintain contact with external parties such as notified body, regulatory authority and or consultants to the quality management system
• Report complaints to authorities and notified body when applicable
• Initiate and approve corrective and preventive actions
• Order material or services on request
Publiceringsdatum2010-02-10Arbetstider och omfattningVisstidsanställning 6 månader eller längre
Heltid
ErsättningFast lön
KontaktJohannes Swartling 0708 23 36 80,
info@spectracure.comFöretagSpectracure AB
AdressSpectracure AB
22643 LUND
KontorsadressMagistratsvägen 10
KontaktuppgifterTelefonnummer: 046-2863770
Jobbnummer 584514
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