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