Job Description

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.Discover more about our company, our team, and our values by visiting us at https://www.ansell.com.Ansell is looking for a Sr Manager, QA to join our team in Melaka.In this position you will play a vital role in maintaining and promoting the highest quality standards and GMP throughout our organization. You will also Lead Plant QA Department and manage the QMS and product regulatory compliance related activities.What benefits and opportunities does Ansell offer?

• Competitive compensation, including a performance-based annual incentives
• An inclusive and collaborative environment that values diversity and fosters an international culture
• Ansell University programs to develop professional and interpersonal skills
• Opportunities to advance and grow within the company

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. Continuously improve Product Quality as measured by Complaint, Outgoing, In Process and Incoming Quality indicators by ensuring and facilitating trend and pareto analysis, effective containment plan, structured problem solving and root cause analysis, effective corrective and preventive actions, proper use of quality tools and continuous quality improvement activities through Lean Six Sigma approach.
• Provide support to all audit functions for manufacturing site policies and procedures and ensure adherence to all Quality Management system and prepare efficient strategies for the plant and ensure efficiency of all tests and recommend improvements implemented accordingly.
• Perform all manual functional tests and development automation tests and coordinate with Quality control team and recommendation quality system improvements and manage all regulatory efforts and ensure compliance to all product requirements and specifications to support regional/global quality, regulatory and marketing 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 to maintain and improve the quality system as well as product quality.
• Manage and monitor supplier performance, establish supplier development program and provide training to key suppliers when necessary. Initiate SCAR (Supplier Corrective Action Request) on critical supplier issues and ensure timely and effective closure.
• Appointed as Quality Management Representative (QMR) in ensuring Quality System is established, implemented, maintained and effective in accordance to international standards such as ISO 9001, EN ISO 13485, FDA QSR (Quality System Regulation), MDD, CMDR, JPMDA, GDPMD, Korea MFDS and other relevant site standards.
• Administer all global quality assurance activities and ensure adherence to all objectives for organization and provide training to all teams for Quality Assurance activities and coordinate with R&D, Technical and Operation.
• Responsible for the development, implementation, and strict adherence to a quality program. develops and/or reviews standards, policies, and procedures for all functions and departments involved with or related to the production of all products and responsibility for products following all regulatory and company standards.
• Implement all Quality Assurance schedule and revise all project deliverables for all available resources and design and efficient Quality Assurance platform and manage all communication and prepare all internal processes for all programs and assist in implementation.
• Ensure plant compliance to established SOP\xe2\x80\x99s and relevant standards and regulations. Manage internal and external audits. Participate in inter-plant audits as requested.
• Develop and maintain an organization structure whereby the QA operations are adequately staffed with key personnel who are trained, developed, motivated, competent and properly rewarded with the opportunity and direction to achieve their maximum potential. Ensure that subordinate staff know and understand their duties and responsibilities and are provided with the necessary means and training in order to meet their position objectives. Lead, direct and delegate authority and responsibility as necessary for them to achieve this
• Interface with sister plant QA Managers. Ansell International QA/ Regulatory personnel and industrial bodies as appropriate. Maintain close contact with marketing regions and senior executives of other companies. Represent the company as directed.
• Ensure that all business activities conducted both personally and by subordinates comply with all Malaysian legal requirements and the highest environmental and ethical business standards as defined by Ansell Melaka.

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 like EN ISO13485, ISO9001, FDA QSR, MDD, GDPMD, Korea MFDS, Japan PMDA etc.
• Trained Lead Auditor, ISO 13845

Join us to lead the world to a safer future, apply today!Equal Opportunity Employer
Ansell commits to securing an equal opportunity recruitment and selection process. All interested candidates are encouraged to apply and will receive consideration for employment regardless of age, sex, gender identity, sexual orientation, race, color, ethnic origin, religion, disability, genetic information, or any other factors that could be deemed discriminatory.Our Commitment to Diversity Equity and Inclusion
Ansell\xe2\x80\x99s vision is about creating safe spaces where diverse perspectives are valued alongside individual contributions. It is our view that togetherness prevails over individuality.When we say that everyone deserves to belong, feel included and empowered at work, it\'s not just words. Rather, it\xe2\x80\x99s what drives Ansell as an organization towards a workforce that reflects the diversity of our community, it\xe2\x80\x99s what drives us to serve our customers and stakeholders with pride, and it\xe2\x80\x99s also what differentiates Ansell. We believe everyone, no matter how that person self-identifies, deserves an opportunity to achieve success.Follow us on Instagram, Twitter, LinkedIn, YouTube and Facebook

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