Supervisor, Product Regulatory Compliance & QMS & ECRN Center

Fresher

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Early Applicant

Job Description

Key Accountabilities

Maintain and update the regulatory testing matrix within alignment with third party labs and Group Legal, regulatory database.
Regularly monitor PANDORA regulatory compliance and ensure all products, materials are in compliance (PSW), Finish product (inhouse, OEM/ODM)).
Assist to strengthen regualtory compliance in E2E process.
Give advice for testing method and testing information relate to regulations test for all stakeholders
Support to review MSDS/test certificate of raw materials/semi finish goods to ensure that Pandora's products comply to the regulatory requirements
Act as the main contact between IT vs Document software vendor , gathering the user experience and feedback to vendor for improve their software functionality, Provide EQMS user guidelines and conduct training for all eQMS users
Facilitate Engineering change request meeting that effect to product/process by address the risky and impact to ensure that modifications are implemented effectively.
Etrablished, Develop, Improve ECRN procedure and collabrate with ECRN local (AAA,BB,LPN) and stakeholders to build and maintain strong relationships, to gain support and promote a positive change environment.
Provide clear and timely communication to stakeholders regarding the change status, progress are taken and sign off on corrective actions upon agreement by committees, Maintain documented remain for all engineering change requests

Qualifications