Quality System Engineer

Responsibilities: - Ensure that ISO13485 and FDA 21 CFR Part 820 systems are adequately maintained, and continuous improvements are implemented - Co-ordinate with various functions to ensure awareness and understanding of the Quality Management System. Plan and co-ordinate gap analysis exercises and provide advice on bridging the gap - Manage and oversee...

Responsibilities:- Ensure that ISO13485 and FDA 21 CFR Part 820 systems are adequately maintained, and continuous improvements are implemented- Co-ordinate with various functions to ensure awareness and understanding of the Quality Management System. Plan and co-ordinate gap analysis exercises and provide advice on bridging the gap- Manage and oversee...

Responsibilities - Responsible for issues with production and IQA quality. - Handle nonconforming material and make repairs by getting in touch with the supplier. - Conduct annual supplier audits and take the lead in evaluating new suppliers. - Annual evaluation and monitoring of supplier quality performance. - Discuss quality performance and the need for...

Responsibilities - Accountable for production and IQA quality problems. - Deal with nonconforming material and perform repairs by contacting the supplier. - Annual supplier audits should be conducted, and evaluation of new suppliers should be led. - Evaluation and monitoring of supplier quality performance are conducted annually. - Once a month, talk to...

Responsibilities- Accountable for production and IQA quality problems.- Deal with nonconforming material and perform repairs by contacting the supplier.- Annual supplier audits should be conducted, and evaluation of new suppliers should be led.- Evaluation and monitoring of supplier quality performance are conducted annually.- Once a month, talk to suppliers...

**Responsibilities**- Ensure proper documentation and updates record on ISO 9001, 14001 and 13485- Perform internal and external audits to ensure readiness for certifications and customer audits- Prepare monthly reports on rejects, return and revised specs and procedures- Review and update Quality Management System procedures to meet the quality system...

Responsibilities - Assist NPI and FAI with new product development and quality control from prototype to mass production. - Ensure that the requirements for new product introduction (FA) and proper documentation are met. - Keep track of the construction and engineering evaluation of the NPI. - Prepare and complete all FA documentation, including the QC/QA...

Responsibilities - Provide assistance to NPI and FAI, as well as oversee the quality of new products from prototype to mass production. - Ensure that the requirements for new product introduction (FA) and proper documentation are met. - Follow-up on NPI construction and engineering evaluation. - Prepare and complete all FA documentation, including the QC/QA...

Responsibilities - Help NPI and FAI with the development of new products and quality assurance from the prototype to mass production. - Ensure that the documentation requirements and new product introduction (FA) requirements are met. - Observe the NPI's construction and engineering assessment. - In order to prepare for production handover, prepare and...

Responsibilities - Assist NPI and FAI, and oversee the quality of new products from prototype to mass production. - Ensure that the new product introduction (FA) requirements and proper documentation are met. - Follow-up on the construction of the NPI and the engineering evaluation. - In preparation for production handover, prepare and complete all FA...