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Ad Description: Staff Engineer/Senior Engineer, Quality Assurance (Medical Device/Pharmaceutical)
(Singapore)



Responsibilities:


Support new product development quality and to establish quality plan and be reponsible for implementation of quality requirements in the project.


Monitor and assess the design develpment processes and to provide objective oversight into the quality of the deliverables, support DHF development and to ensure documentations are robust and processes are validated before transfer to manufacturing.


Ensure project documentaton is consistent and compliance with site/global procedures, standards and regulatory requirements (PCP process, ISO9001, ISO13485, ISO14971, QSR21CFR). Perform compliance audit on each checkpoint to ensure process and regulatory compliance.


Support NPI operation in resolving extended team and functional issues.


Lead Risk management efforts for new products and ensure identification of key poduct/parts paramenters during new product development.

Requirements:


Degree in Quality Assurance, Bio-Engineering, Chemical or related field.


At least 3 year(s) of QA experience in a R&D environment.


Good experience with cGMP and ISO13485.


Knowledge of CE-IVVD and IVD requirement will be an advantage.


High energy level with a positive attitude.


Ability to work independently as well as in a team.


Full-Time positions available.


Applicants should be Singaporean citizens or hold relevant residence status.


Qualified and interested candidates, please forward your resume to: career4@jobsIT.com.sg, stating availability and expected remuneration

For faster processing, kindly forward your resume as a WORD document. We regret that only shortlisted candidates will be contacted.
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