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- Tasks: Lead quality and compliance initiatives, ensuring alignment with regulations and global standards.
- Company: Join a global leader in specialty measurement technologies with over 60 years of innovation.
- Benefits: Enjoy hybrid work options and a dynamic corporate culture focused on growth and development.
- Why this job: Be part of impactful projects that drive continuous improvement in healthcare and environmental science.
- Qualifications: Bachelor’s degree required; 10+ years in medical devices or pharmaceuticals, with managerial experience.
- Other info: Fluency in Japanese and English is essential for this role.
The predicted salary is between 48000 - 72000 £ per year.
Senior Quality Systems Manager About the Role The Senior Quality Systems Manager will lead and oversee quality and compliance initiatives within the region. This role ensures alignment with local regulatory requirements and global quality standards while supporting business operations. Key Responsibilities Maintain and enhance the Quality Management System (QMS) to ensure compliance with global and local regulations. Manage internal and external audit programs to uphold effectiveness and regulatory adherence. Oversee the training and education program , including Learning Management Systems (LMS), to meet compliance standards. Ensure products and processes comply with Quality Agreements between regional and global manufacturing entities. Conduct compliance assessments to identify gaps and drive continuous improvement. Collaborate with leadership to achieve commercial and operational objectives . Represent the regional team in cross-functional, global projects and initiatives. Qualifications Bachelor’s degree in engineering, life sciences, chemistry , or a related field. 10+ years of experience in the medical device, diagnostics, or pharmaceutical industry , with 5+ years in a managerial role . Proven experience in leading or supporting regulatory audits (e.g., ISO, health authority inspections). 5+ years of QMS Lead Auditor experience. Strong understanding of medical device regulations and guidelines . Ability to collaborate effectively with global and local stakeholders . Self-motivated with the ability to work independently in a matrixed organization . Language proficiency: Native in Japanese and fluent in English (written and spoken). Company Overview A global leader in specialty measurement technologies , the company has been at the forefront of scientific innovation for over 60 years. With a presence in 35+ countries , it serves industries such as healthcare, environmental science, food safety, and water quality . #LI-MK2 #LI-Hybrid #J-18808-Ljbffr
Sr QA Manager employer: Barrington James Limited
Contact Detail:
Barrington James Limited Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Sr QA Manager
✨Tip Number 1
Familiarise yourself with the latest regulations and guidelines in the medical device industry. This knowledge will not only help you during interviews but also demonstrate your commitment to compliance and quality management.
✨Tip Number 2
Network with professionals in the field of quality assurance and regulatory compliance. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in the sector.
✨Tip Number 3
Prepare to discuss specific examples of how you've led successful quality initiatives or audits in your previous roles. Highlighting your hands-on experience will set you apart from other candidates.
✨Tip Number 4
Showcase your language skills, especially your proficiency in Japanese. Being able to communicate effectively with local stakeholders can be a significant advantage in this role, so be ready to discuss how you've used these skills in past positions.
We think you need these skills to ace Sr QA Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in quality management systems, regulatory audits, and the medical device industry. Use specific examples that demonstrate your leadership skills and compliance achievements.
Craft a Compelling Cover Letter: In your cover letter, express your passion for quality assurance and compliance. Mention how your background aligns with the company's mission and values, and provide examples of how you've successfully led quality initiatives in previous roles.
Highlight Language Proficiency: Since the role requires native Japanese and fluent English, be sure to clearly state your language skills in both your CV and cover letter. You might also want to include any relevant experiences where you used these languages professionally.
Showcase Continuous Improvement Initiatives: Discuss any specific projects or initiatives where you identified gaps in compliance and implemented solutions. This will demonstrate your proactive approach and ability to drive continuous improvement within quality systems.
How to prepare for a job interview at Barrington James Limited
✨Showcase Your QMS Expertise
Make sure to highlight your experience with Quality Management Systems during the interview. Be prepared to discuss specific examples of how you've maintained and enhanced QMS in previous roles, particularly in compliance with global and local regulations.
✨Prepare for Audit Scenarios
Since the role involves managing internal and external audits, think of scenarios where you've led or supported regulatory audits. Be ready to explain your approach, the challenges you faced, and how you ensured adherence to standards.
✨Demonstrate Leadership Skills
As a Senior QA Manager, you'll need to collaborate with various stakeholders. Prepare to discuss your leadership style and provide examples of how you've successfully led teams or projects, especially in a matrixed organisation.
✨Language Proficiency Matters
Given the requirement for native Japanese and fluent English, be prepared to demonstrate your language skills. You might be asked to discuss technical topics in both languages, so practice articulating your thoughts clearly in both.
