- Selangor Malaysia
Lokasi Kerja
Penerangan Kerja
Tanggungjawab
Job title: NPI Manager
We are representing a international client in medical devices manufacturing and engineering sector to appoint a NPI manager to in charge of NPI department
Job Responsibilities: -
· Oversee the New Production Introduction (NPI), Department.
· Taking the necessary action to ensure that the standards related ISO 13485, GMP, product ISO standards and other regulatory requirements are achieved at all times.
· Initiate/implement projects on new product and improvement /enhancement programmes on existing product in relation to: -
Technical Support to manufacturing and sales
New material investigation & evaluation
New customer technical support
Manufacturing process development
Validation and re-validation activities
Process verification activities
Cost reduction programmes
Implementation of Lean Manufacturing
· Evaluate competitor products when applicable to new development and keep up to date with current changes in technology.
· Review and evaluate change requests from suppliers and customers.
Job Requirements: -
· Degree in Engineering / Science / technology or equivalent
· At least 5 years’ experience in project management / research & development preferably with experience in moulding, assembly and automation process.
· Preferably with working experience in a manufacturing environment that is ISO 13485 certified.
· Preferably with knowledge of ISO 13485, FDA 21 CFR Part 820 and GMP.
· Initiative, creativity, resourcefulness and ability to work independently are essential.
· Good written and spoken English and local language
Peringatan Penting
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