Introduction:
We are seeking a dedicated and experienced QA/QC Executive to join our team in Kuala Lumpur. In this role, you will be responsible for overseeing the quality management functions to ensure compliance with local and international standards, particularly within the medical devices and gloves manufacturing industries. As our company works closely with suppliers and clients both locally and internationally, proficiency in Mandarin is preferred to facilitate clear communication and support our growing business operations.This position is ideal for a candidate with a background in quality management who thrives in a dynamic, fast-paced environment. If you are results-driven, innovative, and possess strong leadership qualities, we would love to hear from you.
RESPOSIBILITIES:
- Responsible for the day-to-day management and co-ordination of the quality function to meet ongoing customer requirements.
- Developing and maintaining the quality system to ensure compliance with local/international standards and regulatory requirements; and quality system requirements, which includes but not limited to the following activities: -
- Maintaining quality system documentation,
- Resolving all the quality matters,
- Monitoring the quality system to comply with relevant standard and regulatory requirements.
- Conduct product inspection at supplier site or remote and ensuring that all requirements outlined in quality specification requirements are comply, effectively implemented and maintained by supplier.
- Ensuring that processes needed for the quality management system are established, implemented and maintained in accordance with ISO 9001, ISO 13485, and US FDA 21 CFR Part 820 (QSR) and other medical devices standard related
- Reporting to top management on the performance of the quality management system and any need for improvement of the supplier.
- Responsibility to assure all parts of the quality system is properly documented and complies with all applicable local/international standards and regulatory requirements.
- Ensure timely preparation and submission of inspection report and filling as well as internal regulatory file documentation.
- Ensuring timely written investigation reports of customer complaints and ensuring that appropriate actions to the complaints have been taken and reported by related supplier as well as customer complaint file documentation.
- Provide relevant support to maintain and improve customer and supplier relations.
REQUIREMENTS & QUOLIFICATIONS:
- A diploma/bachelor's degree or equivalent from an accredited College or University, preferably in Science, Chemistry or Engineering discipline, with minimum 2 years working experience, preferably in a QA and QC environment or working experience in manufacturing environment, preferably in medical devices industry.
- Knowledge of gloves or any medical devices manufacturing process, validation, audit, QMS, Social Compliances, cGMP, FDA in a regulated environment is preferred and an added advantage.
- Ability to perform statistical analysis and strong computer skills are preferred.
- Good leadership skills can work with minimum supervisory.
- Systematic and positive problem-solving approach.
- Good health condition with excellent communication and interpersonal skills.
- Good written and spoken English skills.
- Good planning and organizational skills
- A team-player with the ability to work with colleagues and all levels of management.
- Innovative and a team player who is highly responsive and results driven.
- Applicant must be willing to be stationed in Kuala Lumpur and able to travel frequently.
- Possess a valid driving license and own transportation.
- Proficiency in Mandarin speaking is preferred.
APPLICATION PROCESS:
Interested candidates are encouraged to submit their resume along with a cover letter highlighting their relevant experience and qualifications, salary expectation, and details of your availability via email to [Confidential Information].
