Sr Manager, Quality

Why Ansell?
At Ansell, by staying two steps ahead of workplace risk we aim to deliver innovative safety solutions that enhance people's quality of life. As a global leader in protection solutions, we design and develop a wide range of products including gloves, clothing, and other protective gear, to keep workers safe and productive in industrial, medical, and consumer applications.

Ansell is looking for a Sr Manager, QA to join our team in Melaka.

What your role will be?
Collaborating with our cross functional teams, you will have the opportunity to:

• Close liaison with General Manager to drive company policies on quality and regulatory channeled through Head of Quality - Medical and company authorities for regulatory affairs, at Ansell Melaka.
• Overall responsibility of Quality Assurance for the Melaka plant, which includes Manufacturing Quality Engineering, Incoming, In Process and Final Release Quality Control, Supplier/Material Quality Engineering, Calibration, Quality System, Customer Quality and Complaint Management, Technical File Management, Risk Management, Microbiology/Chemical/Physical Lab Management and Regulatory Affairs.
• Establish, monitor and continuously improve Quality Key Performance Indicators (KPI) which include Product Quality and Compliance indicators.
• Receive and analyze product complaints from marketing, develop and implement programs to overcome weaknesses identified by this process. Provide technical data and information to marketing.
• Provide support to all audit functions for manufacturing site policies and procedures and ensure adherence to all Quality Management system.
• Perform all manual functional tests and development automation tests and coordinate with Quality control team.
• Initiate NC (Non-Conformance) or CAPA (Corrective Action & Preventive Action) on critical product and system non-conformances and drive for effective and timely closure.
• Manage and monitor supplier performance, establish supplier development program and provide training to key suppliers when necessary.
• Appointed as Quality Management Representative (QMR) in ensuring Quality System is established, implemented, maintained and effective in accordance to international standards.
• Administer all global quality assurance activities and ensure adherence to all objectives for organization.
• Responsible for the development, implementation, and strict adherence to a quality program.
• Implement all Quality Assurance schedule and revise all project deliverables.
• Ensure plant compliance to established SOP’s and relevant standards and regulations.
• Develop and maintain an organization structure whereby the QA operations are adequately staffed.
• Interface with sister plant QA Managers and maintain close contact with marketing regions and senior executives of other companies.
• Ensure that all business activities comply with all Malaysian legal requirements and the highest environmental and ethical business standards.

What will you bring to Ansell?

• Minimum 5-10 years of experience in managing Quality department in Medical Device industry, preferably glove industry.
• Experience in managing FDA inspection is an added advantage.
• Experience in driving continuous improvement through Lean Six Sigma is an advantage.
• Must have experience in problem solving and product quality improvement.
• Knowledge in various Quality Systems and Regulations.
• Trained Lead Auditor, ISO 13845.

Join us to lead the world to a safer future, apply today!