Duties of Position: (Include specific duties and responsibilities)
Responsible for all product quality issues including managing internal and external communication on product qualities.
Identification on-going issues and makes recommendations to improve current processes.
Interface with customers and operational groups on quality related issues.
Manage plant wide Quality System in accordance to the ISO requirement to improve and maintain QMS suitability and remain effective.
To be Quality Management Representative
Responsible to host FDA inspections, facilitate response to 483 and warning letter when the needs arises.
Deliver target RMA goals per customer & site requisitions.
Establish medical customer validation requirement interns of Master Validation Plan and execution of IQ/OQ/PQ.
Review and approve the Deviation / Quality Alert / Purge Notice /NCMR/ Stop Build and Stop Ship
Involved in Excursion investigation & 8D compilation. Analyze customer feedback and coordinate proper closure and ensure preventive action is put in place.
Establish Annual Training Plan and source technical/management development training courses
Meet site and corporate commits in terms of revenue, profitability, FCF, inventory turns and dollars and ensure zero risk to customer business.
Management representative in ensuring implementation of the management systems and associated programs, compliance with laws, regulations and codes with regards to Ethics, Labor, Health and Safety and Environment.
Manage IQA/SQE and monitor MRB/RTV aging.
Qualifications Required: (Education, experience, skills, etc. Please be specific)
Preferable Managers specializing in Manufacturing /Quality / Production Operations or equivalent.
Familiar with Medical MDSAP,ISO13485, ISO/TL9000, IATF16949 or related standard.
Knowledgeable in all Medical Validation activities, Quality Control and Improvement technique.
Good presentation skill, communication skill and management skill
Good Rapport and interact with customer, peers and all others.
