A leading global healthcare company is seeking a Quality Assurance Engineer to manage and maintain Quality Management Systems (QMS) and ensure compliance with Japanese Pharmaceutical Affairs Law and ISO 13485. This role will focus on process validation, supplier management, and regulatory audits while contributing to quality improvement initiatives in a pharmaceutical and medical device manufacturing environment.
Key Responsibilities
- Manage and maintain the QMS, ensuring compliance with relevant regulations and standards.
- Analyze quality trends, identify areas for improvement, and implement corrective actions.
- Conduct process validations and oversee quality-related projects.
- Manage and supervise suppliers and outsourced partners to ensure compliance.
- Lead and participate in internal and external audits to maintain high-quality standards.
Required Skills and Qualifications
Experience:
- 3+ years in quality assurance within a pharmaceutical or medical device manufacturing environment.
- Proven knowledge of QMS, Japanese Pharmaceutical Affairs Law, and ISO 13485.
Technical Skills:
- Proficient in English for email correspondence, video conferencing, and report writing.
- Strong analytical and data-driven approach to problem-solving and quality control.
Soft Skills:
- Strong sense of responsibility, initiative, and leadership.
- Excellent communication and collaboration skills.
Language Requirements
- Japanese: Native level (essential for regulatory compliance and audits).
- English: Business level (required for reporting and communication with global teams).
Preferred Skills & Qualifications
- Knowledge and experience with ethylene oxide sterilization and ISO 11135.
- Proven ability to identify and implement process improvements in a regulated industry.
About the Company
Our client is a leading global healthcare company providing medical supplies and solutions to hospitals, retailers, and healthcare providers worldwide. With a strong focus on quality, compliance, and innovation, the company ensures patient safety and operational efficiency across the healthcare industry.
Why You'll Love Working Here
- Competitive salary and benefits package.
- Work-life balance with:
- Five-day workweek (Sat/Sun/bank holidays off).
- Summer, winter, and refresh holidays.
- Paid holidays, childcare leave, and social insurance.
- Flex-time system for improved work flexibility.
- Work in a global company with a strong focus on quality and compliance.
- Career advancement opportunities in a leading healthcare industry player.
Don't Miss Out - Apply Now!
