QMS Manager - Manufacturing

COMPANY PROFILE
Address: Long Thanh District, Dong Nai ProvinceBusiness type: 100% investment from Japan (headquarter in the US)Size: 500-1000 employeesIndustry: ManufacturingProduct range: Medical devices/equipmentEstablished in Vietnam: January 2013
GENERAL INFORMATION
Position: QMS MANAGER - MANUFACTURINGJob code: JO-170706-131564Level: ManagerContract term: Permanent Recruitment reason: New-hiredExpected joining date: Pursuant to Vietnam Labor LawWork location: Long Thanh, Dong Nai (company bus is provided from Bien Hoa and HCMC)Work time: Monday - Friday (8:00am - 5:00pm)Allowance(s): 390.000 VND per month (fixed)Bonus and incentives: 13th month bonus (fixed) / Performance bonus and salary review once per yearBenefit(s): SHUI / Accident Insurance 24/24 / Annual health check / Company tripSelection process: 2-3 rounds
JOB DUTIES
Report to General Manager (US male, 50s)Manage 4-5 staffsJob Responsibilities:- Provide operational leadership for the architecture, process, optimization and consistency of respective QMS programs- Provide intentional influence to ensure that a robust, day-to-day ‘culture of quality’ exists in the company- Work as a primary liaison with the company for quality system program initiatives and process/system alignment; facilitate sharing best practices across regional locations- Ensure that the Quality Management System is implemented and maintained for effectiveness in accordance with applicable standards within scope of Quality Manual (including but not limited to ISO 13485, ISO 14971, MDD, CMDR, FDA Quality System Regulations)- Support continuous improvement of QMS by leading implementation efforts to new and changing requirements and process improvement initiatives- Manage internal audit programs to maintain ISO certification and regulatory compliance- Manage external regulatory compliance audits and relationships with industry groups, regulatory agencies and customers (e.g., FDA, Notified Bodies, Customers, Health Canada and other international regulatory agencies)- Ensure corrective actions and preventive actions (CAPA) are tracked and trended, and that root cause elimination is completed for identified issues by appropriate functions- Communicate to Management Team emerging quality system issues related to internal/external audit and CAPA trends- Ensure QA documentation is maintained; review controlled documentation for quality and regulatory impact as required by regulatory agencies and internal stakeholders- Work with others to develop and implement effective training programs to achieve and maintain quality system and regulation awareness, ISO certifications and Quality System compliance
JOB REQUIREMENTS
Desirable Background and Experience:Qualifications:- Bachelor’s degree or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered- Masters Degree in Engineering or related discipline is preferred- RAC Certification, Lead Auditor Certification, Six Sigma Black Belt (preferable)- Language: English fluent (must)- Proficient in MS Office tools- Professional experience:- From 10+ years of experience working in Quality Management function, with at least 5 years direct experience in medical device manufacturing industry- Experienced in interfacing with global regulatory agencies (US FDA and/or Notified Body inspections, audits and/or other similar regulatory body inspections)- Experienced in interfacing with FDA and/or other regulatory agencies, including preparing for and managing on-site external audits, responding to non-conformities and compiling formal responses (such as FDA 483s and warning letters)- Comprehensive knowledge of US / European and other international regulations, standards and guidance applicable to medical devices (e.g. ISO 13485, 21 CFR 803, MDD, MEDDEV 2.12, MHLW…)- Having Regulatory Compliance / Regulatory Affairs experience involving US FDA Class II or Class III medical devices (preferable)Technical skills:- Must have strong theoretical knowledge of the Quality Management System functions in all primary disciplines, including in-depth practical knowledge of how to apply these principles- Extensive knowledge of US and international medical device regulations and standards- Proven ability to solve practical problems in a collaborative manner which yields effective compliance with QMS and external standards while allowing for the use of efficient and flexible implementation approaches- Proven ability to interact with senior management team, including influencing other members in matters of significance to the organization- Demonstrated ability to organize and motivate cross-functional and multi-facility teams to meet quality goals- Ability to communicate and work effectively as a team member and colleague within functional team processes such as CAPA and audits- Excellent written and oral communication skills and a proven ability to communicate effectively- Proven ability to read and interpret documents of significant complexity, including external standards, design inputs, verification/validation protocols, and clinical studies- External and internal audit extensive experience especially interacting with Regulatory Bodies and the Food and Drug Administration (FDA)- Ability to use and teach methods necessary to facilitate Quality System design and continuous improvement across the company, including process mapping and redesign, project management, metrics selection and monitoringDesirable Characters:- Gender: Any- Age: Any

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