Quality Assurance Specialist
OkloSalary not specified
Full Time
Junior (1 to 2 years)
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Medical Devices, Diagnostics, HealthcareIndustries
Requirements
- University degree or above (any faculty)
- Experience in quality field (5+ years)
- Experience in quality-related work with medical devices or pharmaceuticals
- Knowledge of Pharmaceutical and Medical Device Act (薬機法), QSR, and related regulations
- English: Intermediate level or above (reading/writing and basic speaking; able to give simple presentations or ask questions in meetings)
- Japanese: Fluent level or above
Responsibilities
- Conduct internal audits of the quality management system (as an internal auditor)
- Support external audits of the quality management system
- Report and discuss with the quality process担当者 at US headquarters
- Conduct communication activities for the quality management system (Quality System Management Review / quality meetings)
- Implement quality management system process improvement activities (procedure creation, employee training)
- Manage quality records
Skills
Quality Management System
Internal Audit
External Audit
ISO 13485
QSR
Drug and Medical Device Law
Process Improvement
Procedure Writing
Employee Training
Quality Records Management
English Communication
Danaher Corporation
Water quality, diagnostics, and identification solutions
About Danaher Corporation
Danaher Corporation operates in key markets such as water quality, product identification, and diagnostics. The company provides precision instruments and advanced purification technologies for analyzing and managing water, ensuring its safety in various environments. In product identification, Danaher specializes in laser marking, coding, and packaging solutions that help maintain product freshness and accurate labeling throughout the supply chain. In the diagnostics sector, Danaher offers tools and software that enhance diagnostic confidence, enabling healthcare providers to deliver effective care. What sets Danaher apart from competitors is its unique Danaher Business System, which focuses on continuous improvement and empowers employees to drive change. The company's goal is to consistently deliver high-performance products and solutions while maintaining leadership in its markets.
Washington, District of ColumbiaHeadquarters
1969Year Founded
IPOCompany Stage
Industrial & Manufacturing, Healthcare, Consumer GoodsIndustries
10,001+Employees
Risks
Increased competition from Roche and Abbott in AI-driven diagnostics.
Potential regulatory challenges in the EU for water quality sector.
Supply chain vulnerabilities affecting precision instruments sourcing.
Differentiation
Danaher's Danaher Business System drives continuous improvement and superior financial performance.
The acquisition of Cytiva enhances Danaher's capabilities in the biopharmaceutical sector.
Danaher's advanced purification technologies meet increasing demands for sustainable water management.
Upsides
Danaher's investment in AI-driven healthcare solutions boosts its diagnostics capabilities.
Cytiva acquisition expands Danaher's market share in the biopharmaceutical sector.
Point-of-care testing demand drives growth for Danaher's diagnostic tools and software.
Related Jobs
RemoteRemoteInternal Auditor
Republic ServicesSalary not specified
- Full Time
- Entry Level & New Grad, Junior (1 to 2 years)
RemoteContract Quality and Systems Specialist
GE HealthcareSalary not specified
- Full Time
- Mid-level (3 to 4 years)
RemoteDeputy Compliance Officer
Bitcoin DepotSalary not specified
- Full Time
- Mid-level (3 to 4 years), Senior (5 to 8 years)
RemoteManager, Quality Improvement
HumanaSalary not specified
- Full Time
- Mid-level (3 to 4 years)
RemoteQuality Improvement Coordinator
HumanaSalary not specified
- Full Time
- Mid-level (3 to 4 years)
RemoteRegulatory & Security Compliance Analyst
RainSalary not specified
- Full Time
- Senior (5 to 8 years), Expert & Leadership (9+ years)