A leading global healthcare company is seeking a Quality Assurance Engineer to ensure the safety, compliance, and quality of medical devices. This role is crucial in maintaining regulatory adherence, quality management systems (QMS), and risk management while collaborating with global stakeholders. The ideal candidate will have a strong background in quality assurance, regulatory compliance, and process improvement within the manufacturing or pharmaceutical industry.
Key Responsibilities
- Ensure medical device safety and compliance with industry regulations.
- Manage quality control processes for new products and modifications.
- Collaborate with global stakeholders to align quality standards.
- Investigate and resolve non-conformance issues while implementing improvements.
- Maintain regulatory and QMS documentation to ensure compliance.
- Support risk management, process validation, and manufacturing compliance.
- Handle administrative tasks and project coordination to enhance quality systems.
Required Skills and Qualifications
Experience:
- 5-10 years in manufacturing or quality assurance.
- Expertise in ISO 13485, Japanese Pharmaceutical Affairs Law, and QMS.
- Strong experience in project management and process improvement (PDCA cycle).
Technical Skills:
- Familiarity with domestic and international supplier quality management.
- Strong analytical and problem-solving abilities.
Soft Skills:
- Strong teamwork, collaboration, and a proactive work attitude.
- Ability to communicate effectively and maintain positive relationships with stakeholders.
Language Requirements
- Japanese: Native level (required for regulatory compliance and documentation).
- English: Business level (for communication with global teams and suppliers).
Preferred Skills & Qualifications
- Passion for quality assurance, continuous improvement, and process optimization.
- Logical thinking and decision-making abilities in fast-paced, regulated environments.
- Strong adaptability and flexibility to changing compliance requirements.
About the Company
Our client is a leading global healthcare company, providing medical supplies and solutions to hospitals, retailers, and healthcare providers. With a strong emphasis on innovation, quality, and patient safety, the company is dedicated to enhancing operational efficiency and regulatory excellence in the healthcare industry.
Why You'll Love Working Here
- Competitive salary and benefits package.
- Global work environment with opportunities to collaborate across borders.
- Work with cutting-edge medical technologies and regulatory frameworks.
- Work-life balance with structured leave policies:
- Five-day workweek (Sat/Sun/bank holidays off).
- Summer, winter, and refresh holidays.
- Paid holidays, childcare leave, and social insurance coverage.
- Commuting/transportation allowance.
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