Quality Engineer [English Only]

Nexus Corporation

Job Overview

  • 採用企業タイプ 人材紹介・派遣・委託
  • 業種 医療 / 製薬
  • Salary Negotiable 日本円 /月
  • 英語レベル 流暢
  • 日本語レベル 基本的な会話レベル
  • 国内の応募者に限定? 国内在住応募者のみ
  • ビザスポンサーシップ No

Requirement in Brief:

Ø  Quality Engineer with at least 1 or 2 project in medical domain

Ø  Must worked on medical devices on quality at least for Class 2 or Class 3 devices.

Job Responsibilities:

 

  • Engineering degree with minimum 4-6 years of relevant quality engineering experience
  • Capability in sterilizer/ autoclaves qualification, end to end validation as per the regulatory requirements, temperature mapping and validation of storage facilities.
  • Review new and modified product design documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.
  • Ensure that product development projects and changes to existing products are conducted in compliance with FDA Quality System Regulations.
  • Participate on cross-functional teams to review marketing requirements and to develop concise, unambiguous, non-conflicting and feasible product requirements that support the market needs
  • Participate with cross-functional teams to develop product risk management file (risk management plan, risk assessments, DFMEA, and risk management report).
  • Partner with Software Engineering to assess risk, develop software design plans and documentation, ensure code and integration reviews occur, and to demonstrate software capability and maturity.
  • Assist in the creation of verification and validation plans, protocol and reports. Oversee testing and analysis for standards and product requirements compliance.
  • Provide guidance and direction for sample size and statistical analysis of verification and validation test results.
  • Ensure successful transfer of new products to production facility by assisting in the development of process validation requirements (PFMEA, IQ, OQ, PQ) using appropriate statistical tools and techniques.
  • Review Design History Files and Technical Files for conformance to applicable requirements
  • Participate and provide input to training on department / division procedures and policies
  • Participate when appropriate in internal and supplier audits.
  • Provide Quality support to facilitate resolution of product complaints and/or safety issues

 

Minimum Qualifications

 

  • Engineering Degree from a reputed institution
  • Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Regulations (MDR).
  • Good verbal and written communication skills including protocol / report development and technical presentations.
  • Risk Management – ISO 14971, IEC 62304,IEC 6060 1-1,1-1-2
  • Root cause failure analysis.
  • Previous experience working in a cross-functional team environment.
  • Verbal Communication in Japanese Language (good to have not mandate)

Nice to Have

ASQ CQE, CQA, CSQE and/or CRE certification.

Ø  Target date of Joining –  before end of July

Ø  Contract – Contract (7 Months and extendable based on performance)

Ø  Location of Work : Yamaguchi Prefecture

Ø  Language – English (Monolingual) is also okay.

Ø  Domain preference: Medical/Pharma

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