A leading global healthcare company is seeking a Quality Assurance Engineer to manage and maintain Quality Management Systems (QMS), ensuring compliance with Japanese Pharmaceutical Affairs Law and ISO 13485. This role is responsible for process validation, supplier management, and internal/external audits while continuously improving quality standards within the pharmaceutical and medical device industry.
Key Responsibilities
- Manage and maintain the QMS, ensuring compliance with Japanese regulations and ISO 13485.
- Analyze quality trends, identify areas for improvement, and implement corrective actions.
- Conduct process validations, including cleanroom and heat sealing processes.
- Oversee supplier management and outsourced partners to maintain quality standards.
- Manage and participate in internal and external audits to ensure regulatory compliance.
Required Skills and Qualifications
Experience:
- 3+ years in quality assurance within a pharmaceutical or medical device manufacturing environment.
- In-depth knowledge of QMS, Japanese Pharmaceutical Affairs Law, and ISO 13485.
Technical Skills:
- Strong proficiency in English for email correspondence, video conferencing, and report writing.
- Expertise in process validation and compliance management.
Soft Skills:
- Strong analytical and data-driven problem-solving abilities.
- High sense of responsibility, initiative, and leadership.
- Excellent communication and collaboration skills.
Language Requirements
- Japanese: Native level (required for regulatory compliance and audits).
- English: Business level (necessary for reporting and global coordination).
Preferred Skills & Qualifications
- Adaptability and flexibility in dynamic work environments.
- A continuous improvement mindset and willingness to learn new skills.
About the Company
Our client is a global leader in healthcare and medical device solutions, providing a wide range of products to hospitals, retailers, and healthcare providers. With a strong commitment to quality, innovation, and regulatory compliance, they ensure patient safety and operational efficiency across the healthcare industry.
Why You'll Love Working Here
- Competitive salary and benefits package.
- Flexible work environment with flextime options.
- Work-life balance with:
- Five-day workweek (Sat/Sun/bank holidays off).
- Summer, winter, and refresh holidays.
- Paid leave, childcare leave, and social insurance.
- Commuting/transportation allowance.
- Career growth opportunities in a global healthcare company.
Don't Miss Out - Apply Now!
