Duties and Responsibilities:
- In charge of supervising the Quality Department personal & processes to ensure that all products meet consistent standards.
- Developing and implementing quality control tests, inspection methodology of products at various stages.
- Review quality strategy to ensure its effectiveness to achieve quality objectives and in line with quality policy.
- Implement, maintain, review and improve the quality management system (QMS).
- Regular audits, assessment and report to management of its effectiveness and compliance.
- As Management Representative to liaise with certification or regulatory bodies on external audit or product registration respectively.
- Ensure product conformity and comply with ISO 9001, ISO 13485 and Regulatory requirements.
- Work with other departments to achieve synergy in Quality control system and Operation control system.
- Conduct quality audits on process, plants and suppliers.
- Preparing reports by collecting, analysing and summarizing data.
- Responsible to liaise with customer on any quality related issue or external audits.
- Final release the batch for shipment / final approval for delivery
- Manage staff performance, competency development and training.
- Manage and administer department staff performance and discipline
- Oversee and control department cost and expenditure.
- Perform any other duties as assigned as and when required.
Requirement:
- Degree or Diploma in Quality / Manufacturing / Production / Industrial Engineering.
- Minimum 5 years in quality assurance and at least 3 years in managerial position. Preferably in medical device manufacturing or pharmaceutical industry.
- Hands-on experience in production planning and inventory co Knowledge of ISO 9001 / 13485, 14001, 45001 and cGMP.
- Knowledge of FDA 21CFR part 11/820.(USA) requirements is preferred.
- Experience in statistical techniques (e.g. Sampling Method, MSA)
- Analysis, critical-thinking and problem-solving skills to review systems, find flaws and pose solutions to those flaws.
- Good communication and negotiation skills.
- Computer literate with proficiency in Microsoft Office (Word, Excel, and Power Point).
- Possess strong organizational, communication, and leadership skills.
- Ability to operate under tight deadlines while still meeting standards.
- Team player
