JOB DETAILS

JOB DETAILJob Details

• Maintain necessary licenses for local operations (such as ISO 13485, GDPMD and Establishment Licenses)

• Coordinate and direct all preparations before, during and after any inspections / audits from regulatory authorities or certification bodies (i.e., assuring audit readiness and product compliance with regulations). Ensure any issues arising out of any audits are followed up appropriately

• Maintains, advises and reports on compliance to NKMY quality manual and local requirements and regulations as well as Quality Policies, Quality Objectives and procedures to RAQA Manager and educate other staff on how to achieve them

• Assists in the development and implementation of QA systems and SOPs (standard operating procedures)

• To conduct audit on contract manufacturer and appointed distributors on a regular basis to ensure compliance specific quality and supply management

• Prepare audit reports summarizing quality problems together with recommended corrective actions

• Represent QMR in any audit in the absence of QMR

• Be present for authorities’ audit, internal audits and external ISO13485 / GDPMD audits, and ensure passing

• Manage Engineering Change Notification documents changes and approvals

• Review and analyze annual customer satisfaction survey, complaints received from customers and direct action to reduce the risk of recurrence

• Work closely with sales team to communicate a response if requested / required by customers

• Other duties, responsibilities may be required and / or assigned as necessary

REQUIRED WORK EXPERIENCERequired

• Bachelor Degree in any Science related field or equivalent

• At least 2 years of related experience preferably in medical device industry with QA role. This experience should include progressive responsibility

• Knowledge of Quality and operations systems and processes, including conducting audit for medical devices

• Successful track record in internal audit, third party audit, quality or analysis and development of work progresses

• Able to speak, write and read in Mandarin is required.

Skills or Core Competencies

o Knowledge of ISO 13485 standard requirements, policies and procedures required for the certification to Good Distribution Practice (GDPMD), ISO 17025 or equivalent

o Understanding of the compliance with the medical device regulation under the ‘Good Distribution Practice for Medical Devices’ policy

o Excellent knowledge and experience in the implementation of the Recall Procedure for medical devices and post market surveillance

o Computer literate and proficient in the use of Microsoft Office (Word, Excel, Outlook & PowerPoint).