QMS Manager

This position leads in the developing, implementing, maintaining and management of a Quality Management System that meets the requirements of the ISO 13485, 140001, 9001 quality standards and customer’s expectations.

Responsibilities

Lead in the build, review and implementation of the Quality System with ensuring that it is effective and practical

Co-ordinate with the various operational departments to promote awareness and provide understanding of the Quality Management System

Ensure that the procedures and processes prescribed by the Quality management system are in place and implemented accordingly

Facilitates and coordinates activities and task related to the Quality management system

Provide training on quality system requirements related to ISO 13485, 14001, 9001 and customer expectations. Coordinate and/or provide further refresher training as needed

Work with external parties such ISO Certification bodies, Regulatory bodies and customers for audits relating to the Quality Management System

Plan and lead in the Quality external and internal audits as required

Lead in the understanding of the Quality audit findings and work with parties concerned on the corrective actions to be taken

Ensure that the recommendations and improvements related to the Quality audit implemented

Review the Quality management system periodically to assess continued suitability and areas of possible improvement

Be the organization champion for the Quality management system

Take the lead in Document Control of documents relating to the quality of the product such as Part and Product Drawings, Forms, Standards, Protocols, Procedures, Work Instructions.

Qualifications

Diploma in Quality Management or Business Administration

Minimum 5 years working experience in similar position Excellent knowledge of QMS, EHS, ISO 13485 and other associated Quality System

Minimum two years working experience as a Quality Manager

Minimum two years working experience in conducting training

Good working knowledge of DFMEA, PFMEA and Process Management Plan (PMP) Extensive experience in Document Control, CAPA, Engineering Change and main elements of ISO requirements

Auditor certification is advantageous

Good written and oral communication skills in English

Possess working knowledge of Medical Device Directive or Regulations would be good

Excellent knowledge of MS Office

We are a progressive PMA company located in Batam. Our one-stop solution manufacturing facilities are ISO certified. Our production assembly, plastic injection molding, spray painting, printing, anodising, tooling and other secondary processes are able to provide solutions to global organizations in the consumer electronics, medical, telecommunications, automotive, contract manufacturing and other industries. We require enterprising and resourceful staff to join our organization.

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