BD is seeking a Specialist Quality Engineer to join their team in Fukushima-shi, Japan. In this role, you will plan and execute validation activities, manage calibration programs, and drive quality system improvements within a leading global MedTech company.
Requirements
Bachelor’s degree in Engineering, Science, or a related technical field, or equivalent combination of education and experience.
Experience in Quality Assurance (QA), Quality Control (QC), or Engineering within the medical device, pharmaceutical, or manufacturing industries.
Experience in validation activities and/or equipment management is preferred.
Strong problem-solving skills and ability to work across functions.
Willingness and ability to communicate in English through meetings and emails.
Skills & Responsibilities
Validation: Plan, execute, and review equipment, process, and test method validation including IQ/OQ/PQ documentation.
Quality Systems: Implement global quality procedures, analyze metrics, and drive continuous improvement initiatives.
CAPA and Investigation: Conduct investigations, root cause analyses, and implement Corrective and Preventive Actions.
Calibration Management: Manage and improve calibration programs and records for measuring and test equipment.
Potential transition routes: People from manufacturing QA or validation engineering roles may bring strong technical and quality compliance skills, alongside meeting the engineering degree and industry requirements.
Job description
We are the people who give possibilities purpose
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
Job Description
Key Responsibilities
Plan, execute, review, and continuously improve validation activities for equipment, manufacturing processes, and test methods.
Develop validation protocols and reports, including IQ/OQ/PQ documentation, and drive the associated approval processes.
Manage and improve calibration programs for measuring and test equipment, including maintenance of related records.
Implement global quality procedures and quality system requirements and deploy them at the site level.
Analyze quality metrics and drive quality system improvement initiatives.
Conduct investigations, root cause analyses, and implement Corrective and Preventive Actions (CAPA) in response to quality issues.
Collaborate with cross-functional teams to support site and global projects.
Participate in conference calls and project activities with global teams.
Required Qualifications, Experience, and Skills
Bachelor’s degree in Engineering, Science, or a related technical field, or equivalent combination of education and experience.
Experience in Quality Assurance (QA), Quality Control (QC), or Engineering within the medical device, pharmaceutical, or manufacturing industries.
Experience in validation activities and/or equipment management is preferred.
Strong problem-solving skills and the ability to work effectively across functions and departments.
Willingness and ability to communicate in English through meetings, presentations, and email correspondence.
主な業務内容
設備、プロセス、試験方法などに関する各種バリデーションの計画、実施、レビュー、および継続的改善
IQ/OQ/PQを含むバリデーション文書の作成および承認プロセスの推進
計測機器および試験機器の校正プログラムの運営、改善、および関連記録の管理
グローバル品質手順や品質システム要求事項の導入およびサイトへの展開
品質指標の分析および品質システム改善活動の推進
品質課題発生時の調査、原因分析、是正・予防措置（CAPA）の実施
国内外の関係部門との連携およびプロジェクト推進
グローバルチームとの電話会議やプロジェクト活動への参加
必要な資格・経験・スキル
理工系学部卒業、または同等の知識・経験
医療機器、医薬品、または製造業における品質保証・品質管理・エンジニアリング業務経験
バリデーション業務または設備管理業務の経験があれば尚可
問題解決能力および部門横断的なコミュニケーション能力
英語による会議やメール対応に前向きに取り組めること
Why Join Us?
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.
We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.
