Associate Specialist (RA & QMS)

Understand the Company’s Quality Policy, Environmental Policy, Occupational Safety & Health Policy, that relate to Quality Management System.

To understand and adhere to FDA QSR, ISO 9001, EN ISO 13485 and regulatory standards and requirements such as EU MDD, Korea MFDS, and others the company may need to comply to and ensuring the aforesaid standards and regulatory requirements are established, implemented and well-maintained.

To coordinate and update timely the quality system specifications, standard operating procedures, test methods, etc. with other departments

To maintain document and records effectively and properly in the QA document center and archives

To create and maintain the standardize format of document and record layout for the company documentation.

To coordinate and prepare the Management Review Meeting and report KPI across all department accordingly to schedule.

Review and write procedures and processes to support QMS development, analyze current and future procedural needs. Organize and maintain the plant process or compliance audit and corrective action reporting system.

To be the guardian for the company quality system documentation, to ensure no unauthorized use of the company documents.

To manage and maintain latest standards, specifications, procedures, and records pertaining to standards and regulatory requirements and quality system.

To manage well the product registration and other related tasks relating to traceability and product related matters.

Coordinate external and internal audits and recommend appropriate corrective actions to ensure QMS compliant. To compile overall audit findings and prepare Audit Summary Report and to follow up on the closure of the action items proposed for the respective findings

Prepare, compile, and provide registration documents to regional RA related to product registration.

Maintain technical files for all products manufactured, support regional RA team with technical file documentation

Development and Change of Products Packing Artwork SOPs, to coordinate the change of packaging requirements to ensure products packed by plant according to the approved artwork by Marketing and RA.

To manage barcode and labelling process, including barcode verification and validation

To manage the company’s document control system effectively and securely per standards and regulatory requirements.

Develop or conduct employee quality / regulatory training.

Responsible to Manager / Director, QARA for the effective discharge of duties.

Interface and make recommendations to the Manager / Director, QARA with regards to the record keeping system to help in its maintenance or effective functioning.

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