Quality Engineer - ISO 9001/13485 & Supplier Audits

Rapid Growth Technology Sdn Bhd; Seberang Perai; On-site; MYR 60,000 - 90,000; Full time

Benefits offered by this job

Medical

Group Insurance

Personal accident

Job summary

Rapid Growth Technology Sdn. Bhd. is an ISO QMS certified manufacturer focusing on Washroom Solutions, Automotive Air Care and Medical Devices. The QA Engineer will support QA Manager to maintain customer product quality standards and lead internal audits.

You will liaise with production, conduct supplier audits, prevent recurrence of quality problems, and prepare monthly quality reports, with opportunities to drive vendor development and process improvements.

Qualifications

• Minimum Degree in related field and /or
• Minimum 3 year related working experience
• Able to use measuring equipment
• Knowledge in ISO 9001 Quality Management System and ISO 13485 Medical Device standard
• Experience as Internal Quality Auditor for ISO 9001 QMS
• Knowledge in 8D
• Strong leadership skills and communication skills

Responsibilities

• Ensure quality standards are complied to requirement
• Provide quality records and other performance indicator to the QA Manager whenever required
• Liaise with production department on quality problems and take necessary countermeasures to prevent recurrence
• Responsible in order assist QA Manager to maintain customer product quality standard
• Feedback to supplier on quality issues and follow-up on correction action
• Conduct supplier audit and record supplier performance
• Meet customer and supplier on discussion of quality issues
• Responsible for other related jobs assigned by the QA Manager from time to time
• Authorized to stop loading/production if any abnormality not resolved
• Initiate visit and audit vendor when required
• Initiate vendor development program,records the history of development and evidence
• Provide any special Instruction/Checklist to IQC concerning labeling & packaging to Medical Device
• Station in vendor premises when required to provide necessary support
• Initiate monthly top 3 worst vendor presentation and work together with the vendor on the improvement plan
• Perform source inspection in vendor premises and train vendor to perform source inspection on behalf of RGT-IQC
• Review limit samples and provide suggestion to vendor and superior on the limits where applicable
• Address customer inquiries when required
• Perform internal audit, CTPAT audit and social compliance audit when required
• Monthly IQC report,monthly customer feedback report,ROHS report & MSDS report

Skills

Leadership skills

Communication skills

Measuring equipment

ISO 9001 knowledge

ISO 13485 knowledge

Internal Quality Auditor

8D

QMS knowledge

Education

Minimum Degree in related field

Job description

Rapid Growth Technology Sdn. Bhd. is an ISO QMS certified manufacturer focusing on Washroom Solutions, Automotive Air Care and Medical Devices. The QA Engineer will support QA Manager to maintain customer product quality standards and lead internal audits.

You will liaise with production, conduct supplier audits, prevent recurrence of quality problems, and prepare monthly quality reports, with opportunities to drive vendor development and process improvements.