Quality System Engineer

About the Company

Benchmark Electronics (Thailand) Public Company Limited
Ayudhaya Address : 94 Moo 1, Hi Tech Industrial Estate, Banlane, Bang Pa-In, Ayudhaya 13160
Tel. (035) 276-300 ext. 2010 Fax : ( 035 ) 276-399
Website: www.bench.com

Responsibilities

• Research and keep updated on external medical regulations; update processes as necessary and communicate changes affecting the quality system to concerned parties.
• Identify and coordinate submission of all pertinent information for new medical device product approval and monitor regulatory status of new product developments.
• Participate in the development, execution and approval of process and software validations and ensure validation results comply with customer and FDA requirements.

Qualifications

• Bachelor's Degree in Engineering or Science.
• Knowledge of regulatory requirements for medical devices; ISO 13485 requirement is a major advantage.
• Very good command of written and spoken English; TOEIC > 600 would be an advantage.