Senior Manager Quality (Production Manufacturing)

Our client is seeking an experienced Senior Manager Quality (x1 vacancy) to join their team in Chonburi. This role opens for all nationalties with responsibility for creating, maintaining, and modifying the Quality Management System (QMS). You will be responsible for promoting awareness of regulatory and customer requirements throughout the organisation, ensuring compliance, and driving continuous improvements.

As a Senior Manager Quality, your role will be pivotal in maintaining the highest standards of quality within our client's operations. You will provide leadership to the plant on all QA matters, manage regulatory agency and customer quality audits, and work closely with suppliers to ensure product quality.

The package for this role includes Salary, Provident Fund, Allownaces and Health Insurance

• Create, maintain and modify the QMS in accordance with ISO 13485 and FDA 21 CFR Part 820.
• Regularly report to executive management on the performance of the QMS.
• Ensure that processes and documentation needed for the QMS are established and maintained.
• Provide leadership and direction to the plant in relation to all QA matters.
• Manage regulatory agency and customer quality audits.
• Work with suppliers of both raw materials and services to improve product quality and resolve quality issues.

What you bring:

The ideal candidate for this Senior Manager Quality position brings a wealth of experience from the Medical Device Industry. With at least 8 years of hands-on experience in Quality & Regulatory Compliance Management, you understand what it takes to lead a Quality function effectively. Your knowledge of FDA regulations (21 CFR Part 820), ISO 13485, and other Health Authority regulations is extensive. You have proven experience handling FDA audits, regulatory inspections, CAPA processes, and nonconformance investigations. Your strong leadership skills enable you to drive change management effectively.

• Bachelor’s degree or higher in a science-related field
• Minimum of 8 years of hands-on experience in Medical Device Industry Quality & Regulatory Compliance Management
• Experience leading the Quality function in a managerial capacity
• In-depth understanding of FDA regulations (21 CFR Part 820), ISO 13485, and other Health Authority regulations
• Proven experience in FDA audits, regulatory inspections, CAPA processes, and nonconformance investigations
• Strong leadership, interpersonal, and influential skills

What sets this company apart:

Our client is a leading player in the medical device industry, known for their commitment to quality and regulatory compliance. They offer a dynamic and fast-paced work environment where every team member's contribution is valued. Their focus on continuous improvement and performance metrics ensures that they remain at the forefront of their industry. This is an excellent opportunity to join a company that values its employees and offers opportunities for professional growth.

What's next:

Ready to take your career to the next level with this exciting Senior Manager Quality role? Don't hesitate!

Apply today by clicking on the link. We look forward to receiving your application.

Due to the high volume of applications, our team will only be in touch if your application is shortlisted.

Robert Walters Recruitment (Thailand) Limited
Recruitment License No.: น. 1188 / 2551