- 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.
- 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
- 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