Last updated: 2025-05-22

24 Quality Assurance And Engineering jobs in Tokyo.

Hiring now: Safety Mgr Japan @ Biomarin P, Mgr Quality Assurance Dis @ Regeneron, Mgr Clinical Quality Mana @ Biogen, Lead Spec Regulatory Affa @ Stryker, Post Mktg Surveillance Pm @ Amgen, Hardware Quality Assuranc @ Rakuten Mo, Regulatory Affairs Spec M @ Intuitive , Quality Control Engr @ Mujin, シニアCqvエンジニア Sr Cqv Engr @ Cai, Safety Mgr Japan @ Biomarin.Explore more at at kaamvaam.com

🔥 Skills

project management (6) regulatory compliance (5) pharmacovigilance (4) adverse events (4) training (4) GVP (3) GMP (3) medical devices (3) collaboration (3) compliance (2)

📍 Locations

Tokyo (24)
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Biomarin Pharmaceutical Inc.

Safety Manager - Japan Tokyo
Skills & Focus: pharmacovigilance, adverse events, GVP, compliance, training, regulatory reporting, SOPs, local health authority, audit, safety database
Experience: Minimum of 5 years previous pharmacovigilance experience in Japan as a manager position.

Regeneron

Manager, Quality Assurance & Distribution Tokyo
Skills & Focus: Quality Assurance, GQP, GMP, Pharmaceutical Industry, Quality Management, Deviation, Inspection, Document Control, Quality Improvement, Training
Experience: At least 7 year experience in pharmaceutical industry GMP/GQP as a QA Manager
Type: Contract
Benefits: health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off

Biogen

Manager, Clinical Quality Management Tokyo
Skills & Focus: Clinical Quality Management, SOP, TMF, Clinical Operations, Quality Oversight, Global Audit, Inspection Response, Vendor Management, Budget Management, Contract Management
Manager, Drug Safety Tokyo
Skills & Focus: Drug Safety, Pharmacovigilance, Regulations, Clinical Trials, Signal Management, Compliance, Quality Management System, Process Improvement, Vendor Management, NDA

Stryker

Lead Specialist, Regulatory Affairs Tokyo
Skills & Focus: Regulatory Affairs, approval applications, medical devices, PMDA consultations, QMS compliance, certification, communication, project management, healthcare outcomes, medical insurance
About the Company: Stryker offers innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes. Alongside its c…
Experience: 3+ years of experience of medical device (Class I to IV) application approvals
Type: Full Time
Benefits: Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness …

Amgen

Post Marketing Surveillance (PMS) Sr Associate Tokyo
Skills & Focus: Post Marketing Surveillance, project management, PMS activities, regulatory compliance, data management, process improvement, budget management, collaboration, quality assurance, training
Type: Full time

Rakuten Mobile

Hardware Quality Assurance Lead Tokyo
Skills & Focus: Hardware Quality Assurance, Specification Conformance, Structural Confirmation, Product Verification, Pre-Delivery Inspection, Documentation Management, Risk Assessments, Manufacturing Quality, Quality Control, Factory Audits
About the Company: At Rakuten Mobile, we engage in verification and quality assurance activities for the products we handle, encompassing hardware and software safety, reliabilit…
Experience: Experience in consumer product development and hardware verification; practical experience in auditing production lines and conducting acceptance inspections.

Intuitive Surgical

Regulatory Affairs Specialist – Mandarin Speaking Tokyo
Skills & Focus: regulatory affairs, NMPA, medical device, product registration, regulatory compliance, project management, team collaboration, regulatory submissions, clinical strategy, product lifecycle
About the Company: A pioneer and market leader in robotic-assisted surgery, committed to advancing minimally invasive care through innovative technology.
Experience: Minimum 3 years RA experience, 1 year NMPA requirements
Type: Full-time
Benefits: Comprehensive healthcare, professional development, family support, and equity opportunities

Amgen

QA Manager (External sites management) Tokyo
Skills & Focus: Quality, Compliance, GMP, Audits, Pharmaceutical, Biologics, Regulatory, Manufacturing, Inspection readiness, Risk management
Experience: Doctorate degree & 2 years of directly related experience OR Master’s degree & 4 years of directly related experience OR Bachelor’s degree & 5 years of directly related experience
Type: Full time

Intuitive Surgical

Head of Clinical Research Engineering Tokyo
Skills & Focus: clinical research, engineering leadership, medical devices, robotic systems, clinical studies, product development, regulatory compliance, patient safety, prototype evaluation, team management
About the Company: At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, w…
Experience: 10+ years in medical device development, 5+ years in leadership
Type: Full-time

Mujin

Quality Control Engineer Tokyo
Skills & Focus: quality control, manufacturing inspection, functional testing, vendor reporting, data analysis, quality improvement, internal audit support, standard documentation, interdepartmental communication, robotics
About the Company: Mujin is innovating in the field of industrial automation with its proprietary robotic control technology, MujinMI, transforming supply chains globally.
Experience: Experience in quality control in manufacturing with a background in science (mechanics, materials, or electronics).
Type: Full-time

Cai

シニアCQVエンジニア (Senior CQV Engineer) Tokyo
Skills & Focus: Commissioning, Qualification, Validation, CQV documentation, FDA regulated, Project management, Technical problem-solving, Aseptic processing, Biotechnology, Microsoft Word and Excel proficiency
About the Company: CAI is a 100% employee-owned company established in 1996, that has grown year over year to more than 800 people worldwide. We provide commissioning, qualificat…
Experience: 5 – 12 years in commissioning and/or qualification activities in an FDA regulated industry
Salary: 年収800万円〜1,000万円 (Approximately 800,000 to 1,000,000 JPY)
Type: 正社員 (Full-time)
Benefits: Competitive Salary, Continuing education (internal and external), Opportunities to work on cutting edge projects in a h…

Stryker

Lead Specialist, Regulatory Affairs Tokyo
Skills & Focus: regulatory strategies, advocacy activities, product lifecycle, regulatory classification, compliance activities, regulatory submissions, quality data, clinical data, GCP inspections, project management
About the Company: Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative product…
Experience: Typically a minimum of 4 years’ experience
Type: Full Time
Benefits: bonuses, healthcare, insurance benefits, retirement programs, wellness programs, service and performance awards

Biomarin

Safety Manager - Japan Tokyo
Skills & Focus: pharmacovigilance, safety, regulatory, compliance, adverse events, training, monitoring, audits, GVP, document review
Experience: Minimum of 5 years previous pharmacovigilance experience in Japan as a manager position.
Type: Hybrid

Intuitive Surgical

Project Coordinator Tokyo
Skills & Focus: Project Management, Product Development, Cross-functional Collaboration, Risk Management, Design Control, Regulatory Submissions, Milestone Tracking, Quality Systems, Medical Devices, Process Improvement
About the Company: At Intuitive, we are committed to minimally invasive care through innovative robotic-assisted surgery technology. We foster an inclusive and diverse team dedic…

Biomarin Pharmaceutical Inc.

Safety Manager - Japan Tokyo
Skills & Focus: pharmacovigilance, GVP, regulatory compliance, adverse events, safety information, SOPs, local regulations, training, audit, collaboration
Experience: Minimum of 5 years previous pharmacovigilance experience in Japan as a manager position.

Intuitive Surgical

Senior Mechanical Design Engineer Tokyo
Skills & Focus: design, electromechanical, robotics, medical products, mechanical components, failure analysis, design verification, manufacturing, risk assessments, regulatory compliance
About the Company: At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, w…
Experience: Minimum 8 years of experience designing and manufacturing electromechanical products
Benefits: Market-competitive compensation packages, incentives, benefits, and equity

Rakuten Mobile

After-Sales Service Quality Control Specialist Tokyo
Skills & Focus: After-sales service, product quality control, terminal defects, technical support, market quality control, consumer products, operations experience, quality control work, stakeholders, customer support
About the Company: In Product handled by Rakuten Mobile, we will be responsible for product quality responsibility from the release to the end of maintenance.
Experience: Construction of consumer products after sales service, operations experience; Quality control work experience of consumer products

Cai

Senior CQV Project Manager Tokyo
Skills & Focus: CQV, commissioning, qualification, validation, project management, FDA regulations, pharmaceutical, medical devices, troubleshooting, biotechnology
About the Company: CAI is a 100% employee-owned company established in 1996, that has grown year over year to more than 800 people worldwide. We provide commissioning, qualificat…
Experience: 15+ years in commissioning, qualification, and validation in FDA-regulated industries
Salary: Salary will be determined in accordance with the Company's regulations after due consideration of experience, ability, and other factors.
Type: Full-time
Benefits: Competitive salary, ongoing education (internal and external), opportunity to work on cutting-edge projects in a rapidl…

Amgen

Contract Manufacturing Specialist Tokyo
Skills & Focus: contract manufacturing, cGMP, project management, data analysis, collaborative leadership, regulatory guidelines, continuous improvement, technical writing, problem-solving, influencing skills
About the Company: Amgen is one of the world's leading biotechnology companies dedicated to serving patients and developing treatments.
Experience: 5 years of contract manufacturing management experience
Type: Full-time
Benefits: Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits.

Novartis

Sr Manager / Manager, Global Program Regulatory Manager (GPRM) Tokyo
Skills & Focus: regulatory strategies, drug development, marketing authorization, post marketing products, Japanese labeling, cross functional communication, regulatory activities, MHLW/PMDA, adverse events, mentorship
About the Company: Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives.
Experience: Train and mentor RA members concerning drug development. Understand varied knowledge of Japan regulation.
Type: Full-time

Sqa Services

GMP QMS Consultant Tokyo
Skills & Focus: GMP, QMS, pharmaceutical, consumer, medical device, quality assurance, SOP, assessments, inspections, collaboration
About the Company: SQA Services has been a premier leader in providing managed supplier quality services for audits, assessments, remote surveillance assessments, corrective acti…
Experience: 4+ years of experience in the pharmaceutical, consumer, and/or medical device industries
Salary: $75 - $85 an hour
Type: Full-Time

Veeva Systems

Director Quality Strategy, Japan Tokyo
Skills & Focus: quality strategy, life sciences, quality content management, quality management systems, market share growth, SaaS, public benefit corporation, customer success, employee success, technology applications
About the Company: Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the…
Benefits: Work Anywhere policy for flexibility to work from home or in the office.

Ergomed

Senior PV Officer Tokyo
Skills & Focus: pharmacovigilance, case processing, Individual Case Safety Reports, SAE/SUSAR submissions, regulatory requirements, PBRER, DSUR, PADER, mentoring, continuous improvement