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.
Conducting Pre-Corporate Social Responsibility (CSR) audits to assess ethical and social compliance within suppliers.
- Conducting Quality Management System (QMS) audits to ensure alignment with regulatory requirements and industry standards.
Providing guidance and monitoring suppliers implementation of corrective action plans, developed based on audit findings, for enhancing factory processes and compliance.
Collaborating with sourcing team to ensure new product developments meet quality standards.- Refining/developing product specifications in alignment with regulatory requirements and industry standards.
Maintaining and updating product specifications as necessary to reflect changes in regulations or customer requirements.
- Ensuring consistency and accuracy of product specifications across all relevant documentation.
Collaborating with cross-functional teams to incorporate feedback and ensure specifications meet quality standards.- Implementing quality improvement programs to enhance overall product quality and customer satisfaction.
Participating in cross-functional meetings to provide quality insights and recommendations for process improvements.
- Staying updated on industry trends, regulations, and best practices related to quality assurance and compliance.
Establishing and maintaining comprehensive product inspection plans to ensure consistency and quality improvement.
- Compiling detailed inspection reports for analysis and record-keeping purposes.
Modifying and improving product inspection plans as necessary to enhance quality control processes.- Making informed product release decisions based on quality control results and strategic considerations.
Reviewing and analyzing customer complaints to identify root causes and address issues effectively.- Collaborating with suppliers and clients to implement corrective actions and resolve complaints promptly.
Documenting complaint resolution processes and maintaining records for future reference.
Providing leadership and guidance to quality control staff to ensure effective performance. Conducting regular training sessions on quality control procedures and standards for staff members.
- Assigning tasks and responsibilities to team members according to their strengths and expertise.
Monitoring and evaluating staff performance, providing feedback, and implementing performance improvement measures as needed.
- REQUIREMENTS & QUALIFICATIONS:
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.- Experience managing or operating within an ISO or equivalent quality management system (QMS).
Solid and flawless English communication skills both verbally and writing. Good Mandarin communication will be a plus.
- Solid knowledge of FDA's Quality Systems Regulations, GMPs, ISO 13485, Personal Protective Equipment (PPE) Regulation 2016/425, and ISO regulations/standards.
Advanced analytical and complex problem-solving skills, with experience in driving root cause analysis and corrective action initiatives.- Experience with third-party customer or regulatory audits.
Integrity, discipline, and adherence to principles.
- Excellent communication, negotiation, and organizational skills.
Strong project management and time management skills.- Proactive attitude with attention to detail.
Proficiency in MS Office Suite (Excel, Word).
Job Types: Full-time, Fresh graduate
Pay: RM4,
- 00 - RM5,500.00 per month
Benefits: - Health insurance
Opportunities for promotionSchedule:Supplemental Pay:
Application Question(s):- Do you have experience in medical devices or digital customs product
Experience:- QA/QC: 2 years (Preferred)
Willingness to travel:
100% (Preferred)
