Mes compétences :
Auditor
Conception
Internal Auditor
ISO13485
ISO9001
Lean
Process
SPC
Validation
Entreprises
Covidien healthcare
- Quality engineer
2007 - 2010Major Responsibility:(reported to quality manager)
Start-up phase:
• Set up and follow up the project quality plan.
• Provide strong support for new product development and project transfer, guide the validation implementation to comply with the quality system and relative regulations, review and carry out actions to reduce the risk of process validation failure.
• Build up testing capacity regarding products, including setting up inspection procedures, material/product specifications and qualify testing equipment.
• Support the risk management process (e.g.FMEA).
• Works with teams to identify “Critical to Quality”.
• Set up customer complaints processing capability.
Routine production:
• Perform WIP product release, and complete quality report.
• Identify NCs and CAPAs in a systematic way (e.g. using statistical tools).
• Perform statistical analysis of process data; interpret, compile and organize results.
• Collect and analyze customer complaint data to determine trends and cooperate with engineers for complaint investigation and closure.
• Address product quality issues and organize quality improvement.
• Analyze testing requirements of various products. Propose and implement methods and equipment that would detect defects introduced during the production process.
• Conduct Six Sigma and Lean Six Sigma projects to reduce production lead time, reduce incoming inspection cycle times, improve processes, and improve product quality .
• Manage a group of 5 QCs including hiring, performance review, daily supervision, salary administration, mentoring and training.
• Evaluate work assignments and develop a master schedule for multiple projects to facilitate proper usage of limited labor resources.
• Work as part of a multi-national/multi-functional team to develop, document and implement standards for quality systems.
• Implement and enforce ISO 13485 quality procedures.
• Provide expert contribution to supplier measurement system evaluation.
Achievements:
I successfully transferred 2 production lines (one product is mature, the other one is a new product) from Covidien US to Covidien Shanghai by leading process validation(IQ/OQ/PQ), testing capability setup, customer complaints processing capability setup(surgical products), and SPC implementation. Because of my exemplary dedication and teamwork, I was selected as “2008 Q1 Employee Star”. I launched training of FMEA, PDCA strategy for NCR and CAPA improvements, built up measurement system analysis capability at supplier site and internal site successfully, implemented and enforced ISO 13485 quality procedures.
2005 - 2007Major Responsibility: (Report to quality manager)
• Provide strong support on new product development and project transfer, guide the process to comply with the quality system and relative regulations, review and carry out actions to reduce the risk.
• Make QC flow chart for process control, implement SPC for process control.
• Investigate the rejects and complaints to setup corrective and preventive action, write 8D reports, update FMEA, quarterly quality report.
• Lead a team of 8 QCs to accomplish daily audits and monitor quality status of production.
• Lead Six Sigma projects for improvement.
Achievements:
I successfully transferred two production lines within deadline, ensured their mass production consistent with ISO 9001 and completed two Six Sigma projects with saving 35,208$/year (customer complaints rates were much lower than history data).
