QA & ISO 13485 Document Controller (Latex Industry)

3 weeks ago

Kuala Lumpur, Malaysia AGENSI PEKERJAAN EMCO EXECUTIVES SDN BHD Full time

(i) Quality Assurance: - Devise procedures to inspect and report quality issues - Monitor all operations that affect quality - Assure the reliability and consistency of production by checking processes and final output - Report all malfunctions to production executives to ensure immediate action - Facilitate proactive solutions by collecting and analyzing quality data - Review current standards and policies - Keep records of quality reports, statistical reviews and relevant documentation - Ensure all legal standards are met (ii) Document Control - Manage QMS master lists, scan and filing documents. - Control and manage all quality documents and quality forms including of controlled documents distribution, withdrawal obsolete distributed controlled documents and update document distribution and withdrawal list. - Update Quality Document, such as SOPs, forms, Specifications, etc. - Verify and approve document template format. - Ensure all controlled documents are well maintained. - Handle and manage document review according to document review procedure. - Ensure that all controlled documents are filed in a manner that is easily retrievable. - Ensure all quality records are stored at the location as stipulated in the procedure. - Manage the disposition of quality record after retention period. - Control and manage archive room. - Ensure all document store at archive room can be identified and retrievable easily. - Ensure archive room always in locked condition. (iii) Customer complaint - Register customer complaint received in complaint master list and initiate customer complaint report. - Assist in complaint investigation. - Maintain the customer complaint file and update customer complaint master list. Requirements: - Diploma level education in Engineering or Science - Minimum 2 years' working experience preferably in Quality Assurance/Control section in an ISO 9001 manufacturing environment or medical industry - Knowledge of document control - Knowledge of ISO 13485 and GMP is an advantage - Able to work in a team and with minimum supervision - Initiative, proactive, resourceful and able to multi-tasks - Willing to learn and self-independent - Good written and spoken in English and Bahasa Malaysia - Computer skill - familiar with Microsoft Office
EMCO Execuitve is growing into the leading recruitment consultancy in this region specializing in middle management, senior recruitment and executive level placements. We endeavour to satisfy our client's complete requirements by developing and customizing our services to enable an accurate fit within the specific need, each time. We offer talent management solutions, staffing services, industrial relations consultancy and the management of business process outsourcing, which we have provided to many clients since our inception. We specialize in placing high calibre professionals into permanent positions for all levels across the following areas: 1) Business Process Operations 2) Shared Services & Call Centres 3) Engineering & Technology 4) Manufacturing, Logistic & Warehousing 5) Retail & Commerce 6) Banking, Finance Services & Insurance
Bachelor's or Equivalent

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