ตำแหน่งงานว่างQA Engineer II APAC งานประจำ ตามโครงสร้างบริษ

บริษัทโฮยา ลำพูน จำกัด ในส่วนของโรงงานผลิตเครื่องมือการแพทย์

QA Engineer II APAC

• Oversees and ensures that activities performed by HOYA in the Global Distribution Centre Thailand comply with local regulations and the applicable parts of the HOYA Global Quality Management System
• Responsible for adequate and effective relationship management with regulators, the GDC and other HOYA regional teams, including operations, R&D, GHQ.
• Responsible for ongoing compliance of the Quality Management System and business practices with the applicable regulations by highlighting and implementing regulatory requirements, driving improvement initiatives, and where necessary escalating issues to Senior Management.
• Identification and tracking of any product or process-related non-conformities, escalation to CAPA and quarantine stock handling
• Quality approval related to product labelling and verification activities
• Coordinates CSV (computerized system validation) activities throughout the GDC QMS
• Identifies areas for improvement for the QMS and/or work practices and leads projects in collaboration with the area heads, and where necessary with other QA heads of regions and sites to align on changes and their implementation.
• Responsible for adequate and effective management of external audits in the Global Distribution Centre in Thailand
• Ensures timely complaint transfer, return of complaint samples, as well as effective customer communication on complaints.
• Primary liaison for complaints and product quality in Thailand
• Ensures that reportable adverse events are reported timely to the applicable authorities and ensures follow-up until it is closed.
• Supports the business in solving issues with customers and distributors that relate to quality.

อัตรา : 1

เงินเดือน : ตามโครงสร้างบริษัท

สวัสดิการ :
เบี้ยขยัน, ค่าอาหาร, ค่าเดินทาง, กองทุนสำรองเลี้ยงชีพ, ยูนิฟอร์ม, ค่ารักษาพยาบาล

คุณสมบัติผู้สมัคร : 1. Bachelor’s degree in a technical discipline or comparable education 2. 4 - 6 years of experience in management of quality systems in a regulated environment. Familarity with ISO 13485 is required. Exprience with working with counterparts in other Asian countries is preferred. 3. People skills, project management skills (both written and oral), budgeting skills and analytical skills that demonstrate the ability to recognize when system or staff adjustments are needed. Possession of a good sense of supply chain and distribution is a plus. Ability to communicate technical medical device information. 4. Proficient at process mapping, flowcharting, database systems, Excel spreadsheet, and Microsoft Office. 5. Able to speak and write fluently in English

สถานที่ปฏิบัติงาน :
ศรีราชา, ชลบุรี

จังหวัด : ชลบุรี