Quality Assurance Engineer – Lead & Training

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

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