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Quality Assurance Engineer

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Du bewirbst dich auf diese Stelle:

Ort:
Lausanne, Waadt
Jobtyp:
Festanstellung
Publikationsdatum:
Montag, 22. November 2021
Referenznummer:
16718

Stellenbeschreibung

Our client, an innovative company within medical devices industry in Lausanne is looking for a 

 

Quality Assurance Engineer

 

Start: Asap

Permanent employment

 

Your mission: 

• Continuously improve the company quality system by analyzing KPIs and data such as complaints, non-conformances, CAPAs etc., reporting trends and providing solutions to any quality and technical issues affecting compliance

• Proactively investigates, identifies, and implements best-in-class Quality Assurance practices in regulated industries

• Be responsible for development, preparation, collation or control of all CSV documentation to deliver continued compliance with ISO13485 standard and FDA / EU Regulations

• Interface directly with IT, Engineering and Vendors to develop CSV strategy 

• Provide support for quality system processes and best practices

• Provide Quality compliance expertise and support as required by the organization 

• Create or review documents prepared by stakeholder (e.g. plan, protocols, reports, change controls) 

• Assist in resolution of deviations/ exceptions during qualification activities

• Oversee and administer document lifecycle management as well as the Document Change Request process

• Perform final approval of documents submitted through the change control process for format, completeness and review

• Handle company Quality Audit process

• Conduct QA-RA intelligence/research to maintain current knowledge base of existing and emerging regulations, standards, or guidance documents and recommend changes to company procedures in response to changes in regulations or standards 

• Conduct training on quality assurance concepts and tools to the organization 

• Managing the site calibration program, the coordination of calibration activities and associated documentation.

 

Education & Skills:• Bachelor of Science in an engineering or applied science discipline

• 2-5 years' experience in the healthcare industry

• Detailed knowledge of FDA Quality Systems Regulations, ISO 13485, 21 CFR part-11 and other global regulations and standards

• Experience with statistical analysis concepts and techniques

• Advanced personal computing skills and familiarity with a variety of business software packages including Office, Atlassian tools, ERP and able to learn new technologies quickly

 Language skills:

• Fluent in English (level C1) with minimum B2 level in French