Quality Assurance Engineer (Non IT)

PT Technomed Asia; Kota Bandung; On-site; IDR 200.000.000 - 300.000.000; Full time

Job summary

A medical device manufacturing company in Bandung is seeking a Quality Engineer to lead root cause analysis and quality assessments. The ideal candidate should have over 5 years of experience in the QA field, preferably in the medical device industry. Responsibilities include collaborating on quality inspections, supporting audits, and acting as a QA representative in project teams. Familiarity with statistical methods and documentation is essential. The company offers an innovative environment with a focus on medical accessories production.

Qualifications

• Minimum of 5 years working experience in the QA field, preferably in the medical device industry.
• Knowledge of setting control limits and conducting trend analysis.
• Well-organized with good documentation practices.

Responsibilities

• Lead root cause analysis for quality issues.
• Conduct risk assessments and prepare management plans.
• Collaborate on quality inspections and manufacturing instructions.

Skills

Data processing and analysis

Statistical methods

English communication

Risk management

Documentation skills

Education

Bachelor of Engineering

Tools

Ms Office

Job description

Leads root cause analysis to resolve quality issues (complaints, non-conformities and necessary corrective and preventive actions) in collaboration with relevant departments.

Lead process risk assessments, complete risk management plans and reports.

Collaborate with Engineering/ TE to develop or improve quality inspections, and/or manufacturing instructions.

Collect data and report trend analysis regarding inspection results and/ or other data related to QMS using statistical analysis.

Support Internal and external quality audits.

Act as a QA representative on cross-functional project teams tasked with ensuring projects are executed according to QMS with a particular focus on process control, risk management and documentation.

Support Engineering in developing and reviewing requirements, specifications and technical documents to provide feedback from the QA side.

Become an internal auditor and follow up on the results of the audit

Become a trainer for document training related to job description Quality Engineer or Quality program.

Requirements

Education, minimum Bachelor of Engineering.

Have a minimum of 5 years working experience in the QA field, preferably in the medical device industry with expertise in engineering.

Have knowledge of how to set control limits, and complete trend analysis, with applicable statistical methods.

Accustomed to working using data processing and analysis applications and Ms Office.

Well-organized and understanding of the importance of good documentation.

Able to communicate in English, in verbally and writing.

Proactive and looking for improvement opportunities on own initiative.

Work independently, being able to handle complexity, handling different concurrent tasks and prioritise own work, and have the flexibility to adapt quickly to new priorities.

Technomed Asia is a foreign owned company specialized in the production of medical accessories. Main products are electrodes for EEG (brain studies), EMG (muscle studies) and intra-operative monitoring. Technomed Asia produces accessories under the Technomed brand, as well as for several OEM customers worldwide. Its strength is the production of relatively small quantities of highly customized products. Technomed Asia has its own independent ISO 13485 certified quality system and is FDA registered as well as appointed as a manufacturer of medical accessories for the Japanese market