Manager of Quality Assurance / Regulatory Affairs – PERUSAHAAN GETAH ASAS SDN BHD in Kuala Selangor, Selangor

PERUSAHAAN GETAH ASAS SDN BHD is currently accepting applications for the position of Manager of Quality Assurance / Regulatory Affairs in the Kuala Selangor area. The job type available for this position is Full-time.

We are looking for candidates who possess proficient skills and have a minimum of beginners/seniors in the respective field. In addition to technical expertise, we highly value traits such as honesty, discipline, and a strong sense of responsibility in our prospective employees.

PERUSAHAAN GETAH ASAS SDN BHD operates within the (according to the company) industry. If you are interested in applying for this position and joining our esteemed organization, we encourage you to submit your application promptly.

Job Information

Job Description

Responsibilities:

• Lead, review, and ensure quality assurance operations and systems comply with company, customer, regulatory, and stakeholder requirements.
• Manage and coordinate daily quality functions to meet quality management system, regulatory, and customer requirements.
• Develop and maintain quality systems to meet national/international standards, regulations, and quality system requirements, including but not limited to:
• Maintaining quality system documentation
• Resolving all quality issues
• Monitoring the quality system to comply with relevant standards and regulatory requirements
• Designated as the management representative for quality assurance/regulatory affairs:
• Ensure all requirements outlined in the quality manual are effectively implemented and maintained
• Establish, implement, and maintain processes required by ISO 9001, ISO 13485, FDA 21 CFR Part 820, and/or EU MDR and PPE Malaysia Medical Device Act 2012
• Report on the performance and improvement needs of the quality management system to top management
• Ensure company-wide awareness of applicable regulatory requirements, customer requirements, and quality management system requirements
• Continuously improve the quality management system (QMS)
• Review and ensure the accuracy of quality assurance operations and systems to ensure employees possess the necessary capabilities to provide accurate results and expected performance
• Drive the QA team to consistently perform tasks at the desired level according to defined Key Performance Indicators (KPIs)
• Responsible for ensuring other management system documents applicable to the company are appropriately controlled, maintained, and recorded according to the document control system requirements
• Ensure timely preparation and submission of international regulatory agency forms, as well as internal regulatory documents
• Develop and plan strategies and activities in line with the company’s quality policy and goals of the quality assurance department
• Submit written investigation reports for customer complaints and audit results in a timely manner, ensuring appropriate actions are taken and reported to customers/certification bodies
• Ensure all subordinates consistently adhere to company policies and safety regulations during operations
• Review and ensure the productivity, staffing, and cost targets of QA operations are met according to defined cycle times
• Review and ensure consistent execution of product quality and measurement at each targeted level, as well as compliance with standards, regulations, and customer requirements
• Perform any other tasks and/or responsibilities assigned by management

Benefit

• Overtime bonus
• Gaining experience
• Comfortable work environment

Application Requirements

• Physically and mentally healthy
• Minimum age of 17 years
• Disciplined and punctual
• Honest and responsible
• Good personality
• Enthusiasm in working and learning
• For other requirements, please check through the job form.

Company address