Senior Engineer - Quality Assurance (Based in Vietnam)

Job Highlights
Oversee the daily quality activities including involvement in new project development with relate to technical and non-technical operations.
Responsibilities
Resolves customer inquiries, quality, and operational issues in a timely manner by consulting with the Business Development HOD, Operation Manager, QA Manager, other supporting managers, Superior Manage, lead, and motivate a team of quality inspectors and technicians to meet departmental objectives and goals, create awareness and promote food safety, GDP, GMP and lead by example Champion continuous improvement through effective CAPA system, handling of complaints, analysing key performance indicators and risk management etc Early involvement in new product and project introduction and development to establish and document test plan, specifications and keep abreast of product and customer specific requirements Facilitate and support Notified Body / Regulatory Agency / Customer Audits and Internal Audits activities Improve process capabilities and product quality through leading continuous improvement initiatives, and working with the value stream members, introducing an automate inspection/manufacturing system (whenever possible and applicable), and supervise outcome Establish system for the use of statistics in the improvement and control of quality Lead and manage all non-conformances detected, initiate and responsible for timely closure of all CAPA, non-conformance investigation report, customer complaints, deviations, and follow up on effectiveness. Escalate to superior when required Collate, analyse, trend and report various Key Performance Indicators per management's vision and direction, including indicator(s) of interest, in order, to adhere to process and prevent occurrence of any non-conformity relating to product, process or system Develop, reviews, and approves qualifications and validation protocols (IQ/OQ/PQ), involvement in food Hazard/Medical device Risk management activities and departmental level risk and opportunity assessment, including JSA Establish, document, and maintain departmental Software validation test plan Establish and maintain effective system and procedures to ensure that all quality and manufacturing documentation are controlled and updated per established corporate, statutory, and regulatory guidelines Ensures effective communication internally & externally Ensure department's personnel competency, develop, and retain skill base knowledge within the organisation, through mentoring, coaching, training and identification of training needs Perform any other duties, as assigned by superior
Requirements
Diploma or Bachelor's degree in Biomedical Engineering, Mechanical Engineer, Quality Assurance Engineering Minimum 2 -5 years of experience in a dynamic manufacturing environment Internal Auditor for ISO13485, ISO9001 and certified Quality Engineer is an added advantage Strong knowledge of Statistics, Quality tools and Quality concept fundamentals Skills and ability to perform root cause analysis, process optimization and improvement, data analysis and validation activities effectively in a high-volume manufacturing settling/environment Ability to apply problem solving technique, and provide solutions under minimal supervision Good written and oral communication skills Organized and attention to details Able to multi-task and work as a team
Career Level:Senior Executive The above statements reflect the general tasks, duties, activities and/or responsibilities necessary to describe this position and is not intended to set forth all of the specific requirements of the job. These job duties/responsibilities may change or vary in response to business needs.
Only shortlisted candidates will be notified
Sunningdale Tech is an equal opportunity employer - we believe that a diverse and inclusive workforce will cultivate a vibrant, productive and innovative workplace where all employees are truly respected and valued.
All qualified applicants shall be considered for employment regardless of age, race, gender, gender identity, religion, marital status, medical condition, mental or physical disability, national origin, political and/or third party affiliation or veteran status. All offers of employment shall be conditioned upon successful completion of background checks, valid work passes and medical screenings, as applicable and/or mandated by law, and subject to the applicable local laws and regulations.