In this role, you have the opportunity to
61 Be accountable for oversight of system and hardware quality and risk management throughout the product life cycle.
61 Provide independent oversight of the design input process, design Verification & Validation activities, design transfer and product realization, and performance in the field to ensure that all design requirements are effectively met.
61 Provide analytics to the Business on the efficacy and efficiency of the design and product realization processes
You are responsible for
61 Ensure that appropriate quality plans are made that include all stages of the life cycle of the product and supports Quality Plan design
61 Validate key design inputs like usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs
61 Provide effective oversight of the execution of the Quality Plan, any Risk Management activities, and of all design related activities during the product/system lifecycle
61 Lead the project team to work out the control point from FMEA through control plan.
61 Performs independent technical assessment on product quality performance and post-market product quality analysis
61 Can Lead quality related problem solving and root cause analysis, risk assessment, during design and manufacturing
61 Use post-market analytics and statistics to report on product quality performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiates field actions when required
61 Contact Window to handle customer and market quality issue compliant and feedback
61 Being an ‘ambassador’ for quality assurance and drive quality awareness and improvement in project teams.
61 Compliance, effectiveness and efficiency of the developed product.
61 Act as a single point of contact (person assigned to project team) responsible to ensure that hardware design meets quality and compliance standards for every milestone
You are a part of
61 A professional site production & development quality team with international exposure.
To succeed in this role, you should have the following skills and experience
61 Education: Bachelor’s degree or above.
61 Mechanical Engineering Background preferable in Medical Device type products
61 High Degree of experience working with Global Quality and Regulatory requirements with high dependencies of documented processes and deliverables
61 Experience: More than 3 years of experience in product quality testing and approbation field.
61 Competencies and skills:
o Problems solving Familiar with analytical tools, such as FMEA, process control plan
o Solid knowledge/experience in SPC, G&RR & Process Capability Analysis
o Working knowledge of appropriate global regulations and standards in areas of consumer goods (e.g. Oral Health Care, Consumer Electrical Goods, Medical Device)
o ISO9001 & ISO13485
o Black Belt preferable Green belt minimum.
61 Experience of working in Global Matrix organization
61 High morale with excellent work ethic, integrity and attitude.
61 Teamwork orientated, Self-motivated & able to Work Independently
61 Good quality engineering related tools knowledge and implementation skills.
61 Good team work spirit and communication skills.
61 Good skills of project management.
61 Very good English and Chinese both verbal and written skill.