Job Description

Quality System Coordinator (KL)

Job no: 615670
Work type: Permanent
Location: Kuala Lumpur
Categories: Quality & Regulatory, Asia Pacific, Individual Contributor

A fantastic opportunity for a highly motivated Quality System Coordinator has arisen in Kuala Lumpur, Malaysia. The Quality System Coordinator will be responsible to support the implementation of quality systems processes across Cochlear through the insight documentation review processes and records management, standards process administration, internal and regulatory audit process monitoring and escalation and preparing reports on status and quality system process metrics to ensure accuracy, completeness and effective implementation of the quality system processes. Key Responsibilities In this role you will be responsible for:

• Review insight documentation for quality documentation aspects including currency of references, templates, structure of documents and general good documentation practices as per applicable guidance and support electronic quality documentation control system.
• To monitor the Audit Schedule and follow up with auditors about progress of assigned audit, reports and findings and escalate to the Global Audit program manager where there is a concern.
• To co-ordinate certain Regulatory Audit activities, includes, preparing for Regulatory Audits, conducting pre-audit paperwork, coordinating responses to Regulatory Audit questions as required globally, coordinating updates to the Company profile and Critical supplier list, coordinating request for tender support, compiling and filing all Regulatory Audit Reports / Certificates and managing the associated files accordingly.
• Co-ordinate activities for the standards review process
• Provide support to the Quality system specialists to ensure CAPA and issue management status is up to date and escalate where required and to assist with scheduled Quality System reporting.

Key Requirements

• Minimum Bachelor\xe2\x80\x99s degree in Engineering, Science or relevant
• At least 2 years of experience in Quality system operation in a highly regulated industry.
• Awareness and practical knowledge of 21 CFR Part 820 and 803, and ISO 13485.
• Ability to work effectively both independently and as a member of a cross-functional team.
• Experience in continuous improvement projects. Highly developed analytical, problem-solving and reporting skills.
• Good proficiency in co-ordinate and manage quality systems documentation
• Strong communication skills with demonstrated ability to collaborate.
• Flexible and adaptable with ability to manage multiple priorities to deadline

Cochlear Summary Cochlear Malaysia provides shared services to support Cochlear\xe2\x80\x99s global operations. The growing team of professionals in Malaysia provides critical support in areas such as IT infrastructure and applications, development and testing, business intelligence development and support, procurement, customer service, service and repairs and returned device analysis engineering. If you feel that you have the skills and experience to be successful in this role and take on new challenges to build your career with Cochlear, please start your application by clicking the apply button below. Advertised: 20 Jan 2023 Singapore Standard Time
Anticipated Application Closing: 19 Feb 2023 Singapore Standard Time