MAIN JOB DUTIES/RESPONSIBILITIES：

This individual is responsible for overseeing quality assurance and regulatory affairs for medical devices, ensuring compliance with relevant regulations and standards.

Factory Audit

l Conducting Pre-Corporate Social Responsibility (CSR) audits to assess ethical and social compliance within suppliers.

l Conducting Quality Management System (QMS) audits to ensure alignment with regulatory requirements and industry standards.

l Providing guidance and monitoring supplier’s implementation of corrective action plans, developed based on audit findings, for enhancing factory processes and compliance.

Product Knowledge

l Collaborating with sourcing team to ensure new product developments meet quality standards.

l Refining/developing product specifications in alignment with regulatory requirements and industry standards.

l Maintaining and updating product specifications as necessary to reflect changes in regulations or customer requirements.

l Ensuring consistency and accuracy of product specifications across all relevant documentation.

l Collaborating with cross-functional teams to incorporate feedback and ensure specifications meet quality standards.

l Implementing quality improvement programs to enhance overall product quality and customer satisfaction.

l Participating in cross-functional meetings to provide quality insights and recommendations for process improvements.

l Staying updated on industry trends, regulations, and best practices related to quality assurance and compliance.

Product Inspection

l Establishing and maintaining comprehensive product inspection plans to ensure consistency and quality improvement.

l Compiling detailed inspection reports for analysis and record-keeping purposes.

l Modifying and improving product inspection plans as necessary to enhance quality control processes.

l Making informed product release decisions based on quality control results and strategic considerations.

Complaints Management

l Reviewing and analyzing customer complaints to identify root causes and address issues effectively.

l Collaborating with suppliers and clients to implement corrective actions and resolve complaints promptly.

l Documenting complaint resolution processes and maintaining records for future reference.

Quality Team Management

l Providing leadership and guidance to quality control staff to ensure effective performance.

l Conducting regular training sessions on quality control procedures and standards for staff members.

l Assigning tasks and responsibilities to team members according to their strengths and expertise.

l Monitoring and evaluating staff performance, providing feedback, and implementing performance improvement measures as needed.

REQUIREMENTS & QUALIFICATIONS:

l Bachelor's degree with a minimum of 5 years of relevant experience in Operations/Quality Improvement in medical grade gloves manufacturing. Experience in other disposable medical device manufacturing environments is a plus.

l Experience managing or operating within an ISO or equivalent quality management system (QMS).

l Fluency in English and Chinese (spoken and written).

l Solid knowledge of FDA's Quality Systems Regulations, GMPs, ISO 13485, Personal Protective Equipment (PPE) Regulation 2016/425, and ISO regulations/standards.

l Advanced analytical and complex problem-solving skills, with experience in driving root cause analysis and corrective action initiatives.

l Experience with third-party customer or regulatory audits.

l Integrity, discipline, and adherence to principles.

l Excellent communication, negotiation, and organizational skills.

l Strong project management and time management skills.

l Proactive attitude with attention to detail.

l Proficiency in MS Office Suite (Excel, Word, PowerPoint).