Job Description

Job Responsibilities: -

• 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 technical sales
? New material investigation & evaluation
? New customer technical support
? Manufacturing process development
? Validation and re-validation activities
? Process verification activities
? Machine downtime and performance of production equipment.
? Process efficiency/process improvement
? Preventative maintenance programmes of production equipment
? Process Engineering projects are on time
? 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: -

• Candidate must possess at least a college Degree in Engineering / Science & Technology or equivalent with a thorough working knowledge of High Tech / Engineering principles essential.

• At least three (3) 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 Bahasa Melayu.

• Computer literate.

Skills Required