Job Description

Sirtex Medical is a global leader in healthcare, with offices in the U.S., Australia, Germany, and Singapore, dedicated to improving patient outcomes.

Our mission is to be at the forefront of minimally invasive cancer and embolization therapies. By partnering with physicians, we aim to provide innovative products that enhance patient outcomes and simplify treatments. Achieving this ambitious goal requires passionate and talented individuals who are committed to making a difference. Our flagship product, SIR-Spheres® Y-90 resin microspheres, is a targeted radiation therapy for liver cancer. To date, we have delivered over >150K doses across 50+ countries, significantly impacting patients' lives worldwide. Our success is fueled by our dedication to serving the medical community, maintaining professionalism, fostering a collaborative work culture, nurturing an entrepreneurial spirit, and continuously pursuing innovation and improvement.

At Sirtex, we are committed to creating a great workplace. We offer a range of benefits, programs, and services to support our employees, ensuring they have opportunities to contribute to our success and advance their careers. Join our inclusive community, where you can collaborate with talented colleagues, bring your ideas to life, and advance your career, all while delivering innovative healthcare solutions to patients.

SCOPE:

Based on the strategy of the U.S. headquarters, you will ensure that products manufactured and sold in Japan comply with the QMS Ordinance. Specifically, you will bear direct responsibility for maintaining the quality management system in Japan, under Sirtex Global Quality Management System and, in cooperation with overseas manufacturing sites, ensure that the quality management systems at those sites meet the requirements of the QMS Ordinance.

米国本社のストラテジーを踏まえて、日本において製造販売する製品がQMS省令に適合していることを確実にして頂きます。具体的には、グローバル品質マネジメントシステムの下で、日本における品質マネジメントシステムの維持管理に直接的な責任を持って頂くと共に、海外製造所と協力して、海外製造所における品質マネジメントシステムがQMS省令の要求事項を満たしていることを確実にして頂きます。

Candidates must reside in Japan

PRIMARY RESPONSIBILITIES:

• Establishment, Operation, and Maintenance of Quality Management Systems in Japan
  • Management Review
  • Internal Audit
  • Document and Record Control
  • Training and Education
  • Supplier Management (including management of agreements under Article 72 of the QMS Ordinance)
  • Risk Management
  • Complaint Handling
  • Nonconforming Product Control
  • CAPA
  • FCA
  • External Audit Support
  • Market Shipment Approval

• 日本における品質マネジメントシステム体制の構築・運用・維持

  • マネジメントレビュー

  • インターナルオーディット

  • 文書・記録の管理

  • 教育訓練

  • サプライヤー管理（QMS省令第72条における取り決め管理含む）

  • リスクマネジメント

  • 苦情処理

  • 不適合品管理

  • CAPA

  • FCA

  • 外部監査対応

  • 市場への出荷判定

• Ensuring Overseas Manufacturing Sites' QMS Compliance with QMS Ordinance

  • Training

  • Assessment

  • Improvement

  • Monitoring

• 海外製造所における品質マネジメントシステムのQMS省令への適合

  • トレーニング

  • アセスメント

  • 改善

  • モニタリング

• Regulatory Labeling Management

• 法定表示管理

• Regulatory Registration License Management (e.g. MAH License, Overseas Mfg. Site License, Domestic Selling License, etc)

• 業態管理（海外及び国内）

• Other Quality Assurance Activities (Including Government/Industry Relations)

• その他品質保証に関する業務（行政／業界対応含む）

Qualifications

• Bachelor’s degree (Master’s degree preferred) in Science
• Minimum 5 years’ experience in Medical Device Industry
• Effective project management and administration skills
• Highly organized, exhibiting meticulous attention to detail, excellent record keeping
• Excellent verbal, written, and analytical skills and ability to interact effectively with Sirtex staff

CERTIFICATION:

• Meeting the criteria of 国内品質業務運営責任者(Quality Officer), under Japan Pharma and Medical Device Act

Additional Information

All your information will be kept confidential according to EEO guidelines.

Do you want to be part of something bigger? A team whose impact stretches across the globe making a real difference to the quality of people’s lives. Sirtex recognizes that well-being, financial health, and work-life balance are crucial for our employees to achieve personal success.

Sirtex offers qualified candidates:

• Diverse and flexible work arrangements to achieve the optimum balance between work and personal responsibilities.
• A culture of respect, diversity, collaboration, and innovation fostering inclusiveness and superior performance.
• Attractive compensation and benefit packages which are practical, robust and equitable.
• A commitment to support ongoing professional growth through career development, on the job experiences and training opportunities.
• Challenging work which supports the development of new and better ways to improve clinical outcomes for oncology treatment around the world.
• An unwavering commitment to company values, employee safety and excellence in everything we do.

Diversity drives innovation; inclusion fosters belonging, growth and success. Sirtex believes that it takes multiple perspectives and voices to create a culture and workplace which fosters engagement, teamwork, and employee satisfaction to perform our best and deliver on commitments. We are dedicated to fostering an environment where all employees feel valued, included, and can share their ideas so that we can exceed even our own expectations.

Sirtex is An Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, age or any other characteristic protected under applicable law. Sirtex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.