Position : Quality System Manager

Company : Antmed Malaysia Sdn Bhd

Location: Bandar Springhill, Negeri Sembilan

• According to company development needs, manage the quality system, formulate quality system work plans, assign and guide subordinates’ work to ensure smooth operations.
• Lead the training and promotion of quality system regulations according to the training plan.
• Assist the direct superior in formulating quality objectives and performance appraisal indicators for each department.
• Coordinate and accompany second-party customer audits, third-party regulatory audits, unannounced inspections and provide on-site responses.
• Draft the company's annual internal audit plan and lead internal audits across departments.
• Draft the annual management review plan, verify and evaluate management review data from departments, and report annual results to the Quality Management Representative.
• Assist the technical department in compiling and improving product change documentation, including reviews, validations, and archiving.
• Supervise system engineers in routine quality system inspections and analysis of results.
• Lead quality system audits for Class A critical suppliers and follow up on implementation and nonconformity rectifications.
• Oversee correct implementation of product UDI information and labeling by departments and assist with improvement suggestions when issues arise.
• As the Management Representative, take corrective action and report in the event of serious adverse events or major quality incidents.
• Communicate with Malaysian regulatory authorities (e.g., MDA) as the Management Representative.
• Review and release product batch inspection reports and production records as the Management Representative.
• Assist the Shenzhen headquarters in submitting registration documents to Malaysian regulatory authorities on behalf of the Malaysian entity.
• Organize team-building activities and provide routine training to internal auditors to ensure audit quality.
• Oversee the Document Control Center’s management of documentation.
• Cooperate and coordinate with other departments and take lead as needed.
• Complete temporary tasks assigned by upper management.
• Responsible for departmental quality objectives and KPIs

• Possess bachelor’s degree or above in science and engineering fields related to materials, biology, medicine, mechanical engineering, chemical engineering, electronics, or software.
• Preferably trained in ISO 13485:2016, U.S. 21 CFR 820 QSR, and EU MDR 2017/745/EU regulations.
• Over 5 years of experience in medical device companies in quality, production, technical management, or regulatory roles.
• Proficient in basic office computer operations.
• Good command of Mandarin, English, and Malay.
• Familiar with ISO 13485 quality management system, U.S. 21 CFR 820 QSR, and EU MDR 2017/745/EU regulations.
• Strong reading, writing, speaking, and listening skills in Mandarin, English and Malay.
• Proficient in office software operations.
• Strong coordination and communication skills. Highly responsible and committed. Strong interpersonal skills, judgment, decision-making, planning, and negotiation abilities. Professional, grounded, and dedicated, with strong leadership and team cohesion abilities.