NPI Manager, Medical Devices | Lean & ISO 13485

Mercuri Urval

Klang City

On-site

MYR 120,000 - 180,000

Full time

14 days+

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Job summary

Mercuri Urval represents an international client in the medical devices sector to appoint an NPI Manager responsible for leading the NPI department in Malaysia. The role focuses on ensuring compliance with ISO 13485, GMP, and related regulatory standards while driving new product introductions and improvements.

The successful candidate will oversee technical support to manufacturing and sales, material evaluation, and cost-reduction initiatives, with emphasis on Lean Manufacturing and

Qualifications

Degree in Engineering/Science/Technology or equivalent.
Minimum 5 years in project management or R&D, preferably with moulding/assembly/automation.
ISO 13485 environment and FDA 21 CFR Part 820/GMP knowledge preferred.
Initiative, creativity and ability to work independently.
Good written and spoken English and local language.

Responsibilities

Oversee the New Production Introduction (NPI) department.
Ensure compliance with ISO 13485, GMP, and product ISO standards.
Initiate and manage new product development and improvements.
Provide technical support to manufacturing and sales.
Lead material investigation and evaluation.
Support new customer technical requirements.
Drive Lean Manufacturing implementation.
Review change requests from suppliers and customers.

Skills

Project management

Regulatory knowledge

Initiative

Independence

Education

Bachelor's degree in Engineering/Science/Technology

Job description

The successful candidate will oversee technical support to manufacturing and sales, material evaluation, and cost-reduction initiatives, with emphasis on Lean Manufacturing and

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