QA Manager

Integrated Supply Chain; Gelang Patah; On-site; MYR 120,000 - 150,000; Full time

Job summary

A quality management company in Gelang Patah, Johor, seeks a Quality Management Representative. The role involves compliance assurance, managing quality management systems, and overseeing product quality in a manufacturing environment. Candidates should have a Bachelor’s Degree in Engineering and at least 8-10 years of QA leadership experience, ideally in Medical Devices. Strong leadership skills and knowledge of ISO standards are required. This position plays a crucial role in maintaining high quality standards throughout the product lifecycle.

Qualifications

• Minimum 8–10 years of successful QA leadership in manufacturing.
• 6 years+ experience as a Quality Manager in Medical Devices preferred.
• Proven leadership abilities and solid command of English.

Responsibilities

• Report to the Operation Manager and act as Quality Management Representative.
• Manage nonconformity and implement corrective actions.
• Communicate quality-related issues to customers.

Skills

Leadership

Attention to detail

Time management

Interpersonal communication

Quality management systems knowledge

Regulatory compliance

Education

Bachelor’s Degree in Engineering

Tools

ISO 13485

ISO 9001

cGMP

Job description

Integrated Supply Chain – Gelang Patah, Johor

RESPONSIBILITIES

• Report to the Operation Manager and appointed as Quality Management Representative (QMR).
• Deal with suppliers and vendors to ensure compliance to agreed quality standards or QAA.
• Create and maintain the quality management system (QMS) in accordance with relevant standards and regulations.
• Responsible for managing nonconformity, including investigating root causes, implementing corrective and preventative actions (CAPA), and tracking their effectiveness.
• Keep updated with the latest quality management system practices, including changes in technology, regulatory requirements and expectations.
• Must stay informed about changes in regulations and standards and ensure that the company's quality management system is updated accordingly.
• Process to implement procedures and controls to ensure consistent product quality and compliance throughout the medical device life cycle.
• Process to create, schedule, assign and track training programs to ensure personnel is competent in handling relevant processes.
• Process that oversees the calibration and maintenance of equipment used in device manufacturing to ensure accuracy and reliability.
• Reviewing and approving product release and stability data.
• Communicating with customers about quality-related issues, including audits, non-conformance reports (NCRs), and quality agreements.
• Advise the Production team on matters of quality, process instruction, specifications and protocol requirements as may be required to promote a high product quality standard.
• Ensure optimal performance of the team through effective people management.
• Maintain GMP Systems, including pre-production quality assurance procedures, compliance in coordination with the Document Control and Quality Assurance functions.

QUALIFICATIONS

• Bachelor’s Degree in engineering field from an accredited institution or equivalent discipline.
• Minimum 8–10 years of successful QA leadership of large, complex, multi-team initiatives in a manufacturing environment.
• 6 years and above of working experience as a Quality manager preferably in a manufacturing environment. Experts in Medical Devices field is an added advantage.
• Proven leadership abilities, excellent time management skills with an attention to detail.
• Solid command of the English language in both written and oral form.
• Working knowledge of QMS, ISO and cGMP- ISO13485 & ISO9001.
• Handle the organization licensing such as MDA, FDA & cGMP.
• Must be a certified internal auditor for ISO 13485 or possess internal auditor ISO 13485.
• Preferably ISO 13485 Lead Auditor.
• Excellent interpersonal & communication skills with a pleasant demeanour.