Quality Assurance / Quality Control Engineer

Posted Yesterday
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Hiring Remotely in Ibaraki, Osaka, JPN
Remote
Mid level
Biotech
The Role
The Quality Engineer leads product quality maintenance and improvement efforts, oversees QC processes, responds to customer complaints, and collaborates across teams for continuous improvement initiatives.
Summary Generated by Built In

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Pall Corporation, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. 

You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.

As a global leader in high-tech filtration, separation, and purification, Pall Corporation thrives on helping our customers solve their toughest challenges. Our products serve diverse, global customer needs across a wide range of applications to advance health, safety and environmentally responsible technologies. From airplane engines to hydraulic systems, scotch to smartphones, OLED screens to paper—everyday Pall is there, helping protect critical operating assets, improve product quality, minimize emissions and waste, and safeguard health. For the exponentially curious, Pall is a place where you can thrive and amplify your impact on the world. Find what drives you on a team with a more than 75-year history of discovery, determination, and innovation.

Learn about the Danaher Business System which makes everything possible.

The Quality engineer is responsible for Quality Engineer Our company manufactures ultra-precision filters, primarily used in the semiconductor industry. As one of the world's largest production bases, we maintain high quality standards. In this position, you will lead efforts to maintain and improve product quality, collaborate with overseas teams, and communicate technically in English.

This position reports to the for Quality Assurance Quality Control team manager and is part of

Quality Assurance Quality Control division of Ninon

Pall Manufacturing Ltd. And the  located in in Ami-machi, Inashiki-gun, Ibaraki prefecture. and will be an on-site role.

In this role, you will have the opportunity to:

Quality Control (QC) Work

  • Inspection of raw materials and incoming products, in-process quality checks, and implementation and standardization of final product inspections

  • Identifying the causes of nonconformances and defects, and leading DRB/MRB responses

  • Establishing and improving QC processes, leading process audits and QC patrols

  • Monitoring and reporting on quality indicators (IQC defect rate, in-process defects, number of complaints, lead time, etc.)

Quality Assurance (QA) Work

  • Receiving, analyzing, and investigating causes of quality complaints and inquiries from customers, and formulating corrective actions

  • Preparing and submitting quality investigation reports for customers

  • Visiting customers as needed to explain the investigation results and preventive measures

  • Maintaining and improving quality systems based on QMS (ISO 9001/22301/14001/45001)

    Process Improvement and Data Analysis

    • Establishing and improving SPC (Statistical Process Control) systems, and issuing regular reports

    • Improving metrology, calibration management, and optimizing measurement systems

    • Participate in cross-functional improvement projects aimed at improving productivity and quality.

    The essential requirements of the job include

    • Experience in quality control or quality assurance in the manufacturing industry

    • Experience handling customer complaints

    • Experience operating a QMS compliant with ISO 9001 or similar standards

    • Knowledge and practical experience in statistical quality control (SPC, etc.)

    Travel, Motor Vehicle Record & Physical/Environment Requirements:

    • There is a possibility of overseas business trips to overseas group companies or domestic business trips for training, etc.

    • A driver's license is required for commuting.

    It would be a plus if you also possess previous experience in:

    • At least 3 years of quality-related experience in the manufacturing industry

    • 6 Sigma (GB/BB) certification or equivalent

    • Quality work experience in the semiconductor or microelectronics industry

    • QMS knowledge

    品質 エンジニア

     当社は、半導体分野を中心に使用される超精密フィルターを製造しており、世界最大規模の生産拠点として高い品質基準を維持しています。

    本ポジションでは、製品品質の維持・向上をリードするとともに、海外チームとの協働や英語での技術コミュニケーションも担当いただきます。

    このポジションは、品質保証の品質管理チームマネージャの直属であり、

    茨城県稲敷郡阿見町に所在する日本ポール製造株式会社の品質保証品質管理部門でオンサイトでの勤務になります。

    品質管理(QC)業務

    • 原材料・受入品の検査、工程内品質確認、最終製品検査の実施および標準化
    • 不適合品・不良発生時の原因究明、DRB/MRB での対応主導
    • QCフローの構築・改善、工程監査・QCパトロールの主導
    • 品質指標(IQC不良率、工程内不良、クレーム件数、リードタイム 等)のモニタリングと報告

    品質保証(QA)業務

    • 顧客からの品質クレーム/問い合わせの受付・解析・原因究明・是正処置策定
    • 顧客向け品質調査レポートの作成および提出
    • 必要に応じて顧客訪問し、調査内容や再発防止策の説明
    • QMSISO9001223011400145001)に基づく品質システム維持・改善

    プロセス改善・データ分析

    • SPC(統計的工程管理)システムの構築・改善・定期レポート発行
    • 計測技術(Metrology)の改善・校正管理・測定システムの最適化
    • 生産性・品質向上に向けたクロスファンクショナルな改善プロジェクトへの参画
    • 向けたクロスファンクショナルな改善プロジェクトへの参画
    •  製造業での品質管理または品質保証業務経験
    • 顧客クレーム対応経験
    • ISO9001 等、いずれかに準じたQMS運用経験
    • 統計的品質管理(SPC等)に関する知識・実務経験
    • ビジネスレベルの英語読解力・記述力(英文メール・技術文書作成が可能)
    • 海外チームとの定期的なコミュニケーションが可能なリスニング・スピーキング力
    • 英語会議での簡易説明ができるレベル
      ※同社では英語トレーニングを全社員提供する実績があり、英語は業務で使用する割合は、10%~50%くらいです
    • 海外のグループ会社や、研修等での国内出張の可能性があります。
    • 通勤の為の自動車免許保有の事
    • 3年以上の製造業での品質関連経験
    • 6 Sigma(GB/BB)資格または同等知識
    • 半導体またはマイクロエレクトロニクス業界での品質業務経験
    • QMS知識

    Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

    For more information, visit www.danaher.com.

    Top Skills

    Iso 14001
    Iso 22301
    Iso 45001
    Iso 9001
    Statistical Process Control
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    The Company
    HQ: Sunnyvale, CA
    4,883 Employees
    Year Founded: 1996

    What We Do

    Cepheid is dedicated to improving healthcare by pioneering molecular diagnostics that combine speed, accuracy, and flexibility. The company's GeneXpert® systems and Xpert® tests automate highly complex and time-consuming manual procedures, providing A Better Way for institutions of any size to perform world-class PCR testing. Cepheid’s broad test portfolio spans respiratory infections, blood virology, women’s and sexual health, TB and emerging infectious diseases, healthcare-associated infectious diseases, oncology and human genetics. The company’s solutions deliver actionable results where they are needed most – from central laboratories and hospitals to near-patient settings. For more information, visit http://www.cepheid.com.

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