Subject Matter Expert for Medical Quality System

Job SummaryLead QMS standards establish, risk assessment and internal Audit for medical devices products.Lead to prepare and coordinate the medical devices QMS standards external audits and certification activities.Provide quality technical support to medical devices production, e.g. FMEA, Control Plan, CTQ, equipment/software validation, etc.Lead/support on statutory and regulatory requirements compliance for medical devices products.Conduct medical devices QMS document review and actions follow up.Provide training and knowledge sharing for medical devices QMS requirements.Follow QA SME Manager’s other job assignment.JOB DESCRIPTIONQMS Standards Establish and Internal AuditLead and coordinate the medical devices QMS standard establish in the company, e.g. ISO 13485 and other medical devices related requirements.Conduct risk assessment for workcell & QMS Process and convert into QMS annual internal audit plan, e.g. ISO 13485, ISO 9001, etc.Lead team to conduct regular ISO 13485 QMS internal audit.Lead team to conduct ISO 13485 Management Review.Conduct special audit, such as Change Management, CSR audit, baseline audit, etc.Conduct regular plant level JOS audit.Supervise team to follow up QMS internal audit (especially for medical device business) lesson learnt and work out the systematic improvement action plan in closed loop.QMS External Audit and CertificationLead team to prepare and coordinate ISO 13485 and the other medical devices related external 3rd party audit and certification, e.g. FDA, GMP, CNCA, etc.Take part in and support the other QMS standards external audit, e.g. ISO 9001.Assist workcell to get preparation for customer audit.Supervise team to follow up QMS external audit (especially for medical device business) lesson learnt and work out the systematic improvement action plan in closed loop.Medical Devices Business Technical SupportProduct Quality technical support for medical devices production process, such as review/guide FMEA, Control Plan, CTQ, etc.Guide team to conduct production equipment and software validation (i.e. IQ/OQ/PQ buy off) according to ISO 13485 or other medical devices related requirements.Support team on customer special requirements (CSR) review and convert to internal process when necessary.Drive and support workcell team to collect the best practices and lesson learning for medical devices business.Provide support for workcell quality team’s headcount sizing for medical devices.Lead/Support on Statutory and Regulatory Requirements ComplianceLead to team to establish the process of statutory and regulatory requirements compliance.Guide workcell team to collect, understand and implement medical devices related statutory and regulatory requirements.Provide support to workcell team on government required medical devices registration and authorization application activities.Provide support for customer complaint handling based on corrective and preventive actions process, guide workcell team to support customer for adverse events or issuance of advisory notices to regulatory authorities.QMS Document ReviewConduct global QMS document gap analysis review and provide training if needed, especially for Healthcare/Medical sector related document.Lead team to integrate Global Healthcare/Medical sector related documents into site process/documents.Simplify, Optimize and Standardize the process and revise QMS related document.Lead cross functional team to establish and maintain baseline for medical devices business.Training and Knowledge SharingConduct training about ISO 13485, relative statutory and regulatory requirements, or other medical devices related standards (e.g. FDA, GMP, CNCA, etc.), for newcomer or per operations required.Establish the cookbook for medical devices QMS.Digital SolutionWork out digital solution for QA function or workcell processes and tasks to improve the process quality and efficiency.Follow QA SME Manager’s other job assignment.REQUIREMENTSBachelor or above, worked in Medical Device industry with minimum 10 years quality control or quality management system experience, minimum 4 years’ experience of team leader. Medical or science and engineering related major is preferred.Proficiency in ISO 13485 and domestic/overseas relative statutory and regulatory requirements are the basic, if candidate also has proficiency in FDA, GMP, CNCA, etc. will be priority.Able to communicate clearly and effectively in both verbal and written media.Good at problem-solving skill (e.g., PDCA, 8D CAR, Lean Six Sigma tools, etc.).Skillful at excel data analysis, candidate can use SQL, power BI, python, etc. data analysis tools is preferred.Fluent in oral and written English.

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