This person will handle projects and tasks, handle product/process from inception through launch, and play an active role in the processes to ensure products meet quality standards. Must be familiar with FDA Quality System Regulation 21 CFR Part 820, ISO 13485, ISO 14971 and ISO 11608.
- Oversee local Quality Engineering, Manufacturing Quality Assurance and Quality Control teams
- Ensures that all related design control and production / process control projects meet applicable regulations
- Develop quality plans and work further with Manufacturing on the transfer of quality requirements
- Decide on material disposition in case of process deviations
- Ensures proper design and development documentation as per ISO 13485/FDA QSR Quality System
- Promotes Continues Improvement and Lean Manufacturing processes
Required Skills & Qualifications
- Demonstrated experience in a management position
- At least five years' work experience in a Product Development/Design Assurance function in regulated environment
- Experience in the design and development of products in accordance with ISO 13485 guidelines and ISO14971
- In depth know-how and experience of quality and lean techniques: Six Sigma methods such as DMAIC, DoE, FMEA, MSA, etc., ideally holds a Black Belt certification
- Experience in modular automation/fully automated assembly processes, particularly those involving plastic injection molded parts, mechanical spring, with integrated/non-integrated testings
- Experience in the entire Design life-cycle and Phase-Gate development process.
- SAP (Manufacturing Execution Systems / MES will be an advantage)
- Able to travel internationally (up to 10%) after a 6-month introduction period in Taiwan