Job title: Quality Engineer (Medical Device)
Job type: Permanent
Emp type: Full-time
Industry: Medical Device
Functional Expertise: Quality Assurance/ Quality control
Salary type: Monthly
Salary from: THB ฿40,000.00
Salary to: THB ฿45,000.00
Location: Pakkret, Pak Kret District, Nonthaburi 11120, Thailand
Job published: 2024-10-31
Job ID: 126733
Contact name: Nattaporn Tangkanchanaverukul, Nutcharee Phontawee
Phone number: +66880026365

Job Description

Our client is a pioneering medical device company based in Thailand, specializing in the development, manufacturing, and distribution of cardiovascular interventional devices. Currently, They are seeking a Quality Engineer who has experience in validation and calibration processes to be a part of their team.

Responsibility:

Quality Control & Monitoring

  • Oversee and monitor all quality-related activities throughout the production process.
  • Perform in-process quality checks and inspections.
  • Conduct data analysis and provide solutions for product sustainability issues.
  • Handle and process test batch requests for new processes and troubleshooting.

Documentation & Reporting

  • Generate and maintain quality-related documentation.
  • Prepare Process Validation protocols and reports.
  • Develop and manage Post-Market Surveillance (PMS) reports.
  • Create Initial Validation Report (IVR) documentation.
  • Maintain and update design files.
  • Conduct gap analysis of QA-related documents.

Technical Operations

  • Manage the installation and calibration of equipment.
  • Perform troubleshooting activities.
  • Coordinate with external testing laboratories.
  • Optimize processes as required.
  • Evaluate test pieces according to specifications.

Quality System Management

  • Initiate and process Change Control/CDCR documentation.
  • Ensure compliance with GMP standards.
  • Coordinate external testing requirements.
  • Maintain communication with testing laboratories.
  • Provide training to employees on rejection control and GMP procedures.

Qualifications:

  • Minimum of 2 years of quality control experience.
  • At least 1 year of experience in the pharmaceutical or medical device industry.
  • Proven background in validation and calibration processes.
  • Thorough knowledge of ISO 13485 and ISO 9001 requirements.
  • Familiarity with Medical Device Regulations (MDR) or Medical Device Directives (MDD).
  • Strong analytical and problem-solving skills.
  • Excellent documentation and communication abilities.
  • Very good English.

Working hours: Mon - Fri.
Location: Nontaburi.