Additional details:
Maintain the QMS to fulfill quality and regulatory requirements:
Authors new or revised site procedures as assigned.
Assures compliance of local QMS procedure and updates as required.
Maintains the effectiveness of the QMS in accordance with the company objectives and applicable requirements
Executes QA activities in line with defined procedures and processes: CAPA non-conformities, training, control.
Ensures that all suppliers used by the company are selected, evaluated and re-evaluated.
Ensures quality records are established and maintained to provide evidence of the QMS effectiveness.
Review, edit and approve change controls, work-instructions, reports and other ation.
Maintain the QMS to fulfill quality and regulatory requirements:
Authors new or revised site procedures as assigned.
Assures compliance of local QMS procedure and updates as required.
Maintains the effectiveness of the QMS in accordance with the company objectives and applicable requirements
Executes QA activities in line with defined procedures and processes: CAPA non-conformities, training, control.
Ensures that all suppliers used by the company are selected, evaluated and re-evaluated.
Ensures quality records are established and maintained to provide evidence of the QMS effectiveness.
Review, edit and approve change controls, work-instructions, reports and other ation.
Requirements:
Relevant degree (e.g., biomedical engineering or related science / technical discipline)
Experience with Class III in a medical device company
Experience and knowledge with standards and regulations (MDR 2017/745, ISO 13485, FDA QSR)
Experience with statistical techniques, risk analysis
Excellent English language skills (verbal and writing)
CQE and process validation knowledge
Experience with working in controlled environment (clean room)
Relevant degree (e.g., biomedical engineering or related science / technical discipline)
Experience with Class III in a medical device company
Experience and knowledge with standards and regulations (MDR 2017/745, ISO 13485, FDA QSR)
Experience with statistical techniques, risk analysis
Excellent English language skills (verbal and writing)
CQE and process validation knowledge
Experience with working in controlled environment (clean room)
This position is open to all candidates.
