1. トップ
  2. 求人検索
  3. 求人検索結果
  4. QA Specialist

投稿日:2022/08/10

(社名非公開)

QA Specialist

ポジション情報

職種 品質保証・品質管理
雇用形態 正社員(期間の定め無し)
勤務地 東京都
給与 600万円~800万円
給与(詳細) 経験・スキルをもとに優遇
職務内容 〇 Assumes the role and responsibilities of QA management in the areas of quality assurance, Safety control (preferable) and Quality Affairs Specialist for Cutera KK
〇 Collect, provide and analyze quality and safety information; create SOPs and documents; create and retain quality records,
〇 Support complaint handling and an effective complaints management process
〇 Works as the Post-Marketing Safety Controller to ensure processes are compliant and reporting to the authorities with Good Vigilance Practice.
〇 Ensures the safety and quality activities meet customer, Corporate, and internal requirements as well as any other related requirements within the Quality Management System.
〇 Coordinates with Cutera Headquarters for investigation, product disposition, management or support of deviations, change control, and NC/CAPA processes related to safety issues throughput the product life cycle.
〇 Develops, reviews, and approves Good Vigilance Practice documents to ensure compliance with applicable regulations, product laws, and corporate requirements
〇 Manages and/or performs internal and external Good Vigilance Practice compliance audits/inspections as well as participate in management of corrective action program, in line with global standards.
〇 Maintains current knowledge, excellent comprehension, and appropriate application of relevant regulations.
〇 Communicates with and updates Cutera headquarters management teams on a regular basis.
応募資格 〇 University degree (preferable), BS (preferable)
〇 At least three years of experience in safety control work and meet other requirements required for Safety Management Controller of Medical Device under the law. (Experiences in Regulatory Affairs is a plus.)
〇 Fluent communication skill in English (mainly by e-mail and sometimes face-to-face/phone conference)
〇 An understanding of relevant GVP regulations and requirements, as well as ISO 13485 and/or ISO 9001

企業情報

募集企業 (社名非公開)

コンサルタントに相談する

PAGETOP