JOB DETAILS

JOB DETAIL

• Technical Reviewer
- Review and assist product documents to ensure all product requirements are met
- Control Quality System Documents of Benchmark (Thailand)
• Leader of Regulatory requirements deployment
- Ensure company is up to date on all regulatory requirements as they apply to ISO standards and products and services of the company
- Review and develop internal system documents to comply with the regulatory requirements
- Ensure applicable regulatory requirements are fully implemented and maintain
• Leader of Customer requirements deployment
- Ensure company is up to date on customer requirements
- Review and develop internal system and/or product documents to comply with the customer requirements
- Ensure customer requirements are fully implemented and maintain
• Agile Developer
- Develop and maintain External Documents Management
- Initiate ECR/ECO Tracking
• AssurX Developer
- Initiate Customized CAPA reports
- CAPA review and approval
• CRB chairman
- Coordinate with other departments to provide effective corrective and preventive actions to eliminate the causes of Quality System Non-conformances
- Lead Continuous Improvement team for product quality perspective
• Regulations and QMS Training Provider
- Manage training activities of the Regulations and QMS to ensure that all positions are properly trained.
- Ensure training techniques and information is up to date with all standards and regulatory requirements

REQUIRED WORK EXPERIENCE

- Bachelor’s degree in Engineering or related fields, Master’s degree is advantage.
- 8+ years’ experience with Quality System / Regulatory affairs in Medical or Regulated Product Manufacturing (Medical, Automotive, Aerospace) and 10 + year’s experience in Problem Solving Techniques for Manager level.
- At least 5-7 years’ experience in Electronic fields/regulated industry and quality system for Senior Engineer level.
- Good command in English spoken and written.
- TOEIC 650+
- Professional auditing experience preferable.
- Lead auditor or internal auditor of Quality System Management Certification (ISO9001, ISO13485, IATS16949, AS9100 is Preferred)
CQE or other Quality knowledge