Assistant/ Engineer, QA

Ennovi Medical Sdn. Bhd.; Parit Buntar; On-site; MYR 56,000 - 100,000; Full time

Job summary

Ennovi Medical Sdn. Bhd. in Parit Buntar, Perak, Malaysia is seeking a QA/QC professional to define inspection items for new products and to reject non-conforming material or online defects until issues are rectified.

You will approve documents on behalf of the QA Manager when needed, stop production for non-conforming parts, and assist in implementing ISO 13485, ISO 14971, ISO 14644, and FDA requirements. You will liaise with customers and suppliers, lead a team, and train subordinates in QC/QA

Qualifications

• Degree in Mechanical, Material, Chemical, Science or equivalent Engineering fields.
• Minimum 2-3 years' experience in manufacturing industries.
• Communication skills with customers.
• ISO 13485 knowledge is an added advantage.
• Fresh graduate with track records in engineering.
• Computer and data entry skill.
• Organizational skill.
• Ability to handle precise parts.

Responsibilities

• Define inspection items for new products.
• Reject non-conforming material or reject online until the problem is rectified by Production / Tooling Department.
• Approve documents on behalf of QA Manager when absent with consent.
• Stop production if non-conforming parts are found and report to QA Manager and Production Leader.
• Assist QA Manager in implementing and maintaining ISO 13485, ISO 14971, ISO 14644, and FDA regulatory requirements.
• Liaise with customers / suppliers on customer requirements, complaints, production quality improvement, material defects and quality related matters.
• Lead and supervise a team of subordinates.
• Provide training to subordinates on QC / QA related functions.
• Conduct quality related training support to other departments as required.
• Initiate and monitor regular quality improvement activities.

Skills

Leadership

Communication with customers

Training and development

Quality mindset

Organizational skills

Attention to detail

Analytical thinking

Education

Degree in Mechanical / Material / Chemical / Science or equivalent Engineering fields

Job description

Define inspection items for new products

Reject non-conforming material or reject online until the problem is rectified by Production / Tooling Department

Approve documents on behalf of QA Manager when absent with consent

Stop production if non-conforming parts are found and report to QA Manager and Production Leader

Assist QA Manager in implementing and maintaining ISO 13485, ISO 14971, ISO 14644, and FDA regulatory requirements

Liaise with customers / suppliers on customer requirements, complaints, production quality improvement, material defects and quality related matters

Lead and supervise a team of subordinates

Provide training to subordinates on QC / QA related functions

Conduct quality related training support to other departments as required

Initiate and monitor regular quality improvement activities

Education and/or Experience Requirements

Degree in Mechanical, Material, Chemical, Science or equivalent Engineering fields

Minimum 2-3 years' experience in manufacturing industries

Communication skills with customers

ISO 13485 knowledge is an added advantage

Fresh graduate with track records in engineering

Computer and data entry skill

Organizational skill

Ability to handle precise parts