This position has mainly following responsibilities and authorities to timely deliver effective and safety products in Japanese market, to reduce customer complaint/malfunction, and to improve product quality:
• Lead risk management team and implement risk management activities from the viewpoint of product and subcontractors / suppliers in cooperation with related functions.
• Assess change notifications from headquarters and manufacturing sites, and implement necessary actions in cooperation with related functions.
• Evaluate customer complaints from the viewpoint of product quality, report to ISI and manufacturing sites, and evaluate the analysis result in cooperation with Safety Control team.
Furthermore, create customer letters, and communicate to customers to solve the quality issue with Marketing, Sales, Field Service and Safety Control teams.
• Completing quality issues by working with regulatory agencies, customers and related functions.
• Collaborate with Product Quality team and Safety Control team to reduce customer complaints from the viewpoint of product.
• Involve in implementation of a field action like recall.
• Collaborate with QRC team to maintain Quality Management System.
• Work related to product realization (control DMRs and materials for released products etc.).
• Operate product release (IQC, labeling instructions, and market release assessment etc.).
• Manage non-conforming products (rework, concession, and hold etc.).
• Work related to data analysis and CAPA.
Background:
• Minimum 3 years experience in Pharmaceutical/Medical Device/IVD industries or Minimum 3 years experience related to Quality in any manufacturing industries
Skill / Experience:
• Good interpersonal/communication skill to work well with cross-functional teams
• Analytical mindset and ability to see the big picture
• Project management skill
• Logical thinking skill
• Strong willing to achieve goals
• Verbal and written communication in English and Japanese
• Knowledge of basic Quality Management System (e.g. ISO 9001) / Quality Assurance / Quality Control methodology
• Basic PC skill (e.g. Microsoft Word /Excel / PowerPoint)
Required Education and Training:
• Bachelor or higher degree (Preferred: Physics, Chemistry, Biology, Material Engineering, Electrical Engineering, Mechanical Engineering or Pharmacology)
Preferred Skills and Experience (As applicable - Specific skills, knowledge, and experience that are not required to perform the job, but are desirable to have)
• Knowledge of J-PMD Act, relevant regulations, ISO 13485 and ISO 14971
• Experience of complaint handling and/or complaint product investigation
• Experience of using Oracle Agile PLM, SAP, Trackwise, and/or HP ALM
当社は、法令に従い、全ての応募者について、その適性と能力のみを基準として公正に採用選考を行います。
この職位は、業務上のニーズや、採用候補者の経験、知識、技能に応じて、ここに記載されている職務レベルと異なるレベルで採用される場合があります。
報酬は、主に採用された職務レベルと候補者の資格に基づき、適用される法律に従って決定されます。
Skills Required
- Minimum 3 years experience in Pharmaceutical/Medical Device/IVD industries or 3 years quality-related experience in manufacturing
- Bachelor degree or higher
- Good interpersonal and communication skills for cross-functional collaboration
- Analytical mindset and ability to see the big picture
- Project management skills
- Logical thinking skills
- Strong will to achieve goals
- Verbal and written communication in English and Japanese
- Knowledge of basic Quality Management System (e.g. ISO 9001) / Quality Assurance / Quality Control methodology
- Basic PC skills (Microsoft Word, Excel, PowerPoint)
- Knowledge of J-PMD Act, relevant regulations, ISO 13485 and ISO 14971
- Experience of complaint handling and/or complaint product investigation
- Experience using Oracle Agile PLM, SAP, Trackwise, and/or HP ALM
Intuitive Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Intuitive and has not been reviewed or approved by Intuitive.
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Healthcare Strength — Healthcare coverage appears broad and modern, including medical/dental/vision, telehealth, second-opinion services, fertility support, and condition-specific programs. Mental health support is positioned as strong, including access to free counseling sessions and a dedicated counseling service.
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Wellbeing & Lifestyle Benefits — Wellbeing and lifestyle offerings extend beyond core insurance, with initiatives such as vaccination clinics, fitness memberships, stress-reduction programs, and employee assistance programs. Additional lifestyle perks include curated discounts, pet insurance, identity theft prevention, and paid volunteer time.
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Flexible Benefits — Flexibility is supported through flexible work schedules and telecommuting options that can help with work-life integration. Benefit availability is described as variable by country, campus, and role, implying a menu that changes by eligibility and location.
Intuitive Insights
What We Do
Intuitive (Nasdaq: ISRG), headquartered in Sunnyvale, Calif., is a global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery. At Intuitive, we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. Intuitive brings more than two decades of leadership in robotic-assisted surgical technology and solutions to its offerings, and develops, manufactures, and markets the da Vinci surgical system and the Ion endoluminal system.
Why Work With Us
We bring together the thinkers and doers; those who pursue excellence and are energized by discovering ways to do what can’t yet be done. We question, we test, we challenge each other and the status quo until we see the impact we’ve made, until we’ve set a new standard for minimally invasive care. We revel momentarily in our achievements before sta
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