Analyst,QA

Why Ansell?

Ansell is a world leader in providing superior health and safety protection solutions that enhance human well-being. As the need for better protection continues to grow, Ansell remains committed to researching, developing, and investing in innovative products and technologies that are marketed under trusted global brands. Operating across two business segments—Industrial and Healthcare—Ansell employs approximately 14,000 people worldwide and continues to grow as a market leader.

For more information about our Company, our People, and our Values, please visit\: https\://www.ansell.com

Ansell is looking for an Analyst, QA to be based in Ayer Keroh, Melaka.

This position is responsible to develop, administer and maintain quality assurance procedures and activities required to ensure that the company's processes and products comply to the medical device quality standards. Analyzing, identifying and implementing manufacturing and process improvements which will improve capability and performance that leads to products and services are of the highest quality. Develop and implement quality control and inspection procedures for receipt and control of incoming materials, in-process inspection/testing and final product acceptance activities. Define quality control standards and test; specify test equipment and procedures. Active participation in all stages of design development, manufacturing and testing, ensuring compliance to quality assurance requirements.

What Can You Expect from Ansell?

• Work for a global leader in the health and safety protection solutions industry.
• A secure workplace with competitive remuneration and annual performance bonuses.
• An inclusive, collaborative, and supportive work environment.
• Exposure to a diverse and international workplace culture.

What Will Your Role Be?

• Understand the Company’s Quality Policy, Environmental Policy, Occupational Safety & Health Policy, etc.
• To understand the implications of improper job performance and the need for quality work.
• To be aware, committed & responsible to understand the importance of protecting the environment by ensuring all activities and practices will safeguard the environment, and in compliance to Environmental requirements.
• To understand and adhere to FDA QSR, ISO 9001, EN ISO 13485 and regulatory standards and requirements such as JPMDA, GDPMD, EU MDR, Korea MFDS and others the company may need to comply to and ensuring the aforesaid standards and regulatory requirements are established, implemented and well-maintained.
• To coordinate and update timely the quality manual, quality system specifications, standard operating procedures and other relevant documents.
• To review, plan, coordinate and organize the schedule of overall activities for QA operation at FRC according to internal and external standards.
• To manage and supervise QA operation personnel on daily work activities to ensure QA operation inspection is carry out according to documented procedure, inspection method and work instruction.
• To prepare data compilation, monitor trend analysis, conduct investigation related to finished product inspection result failure and also inspection method used by inspectors and operators.
• To ensure FRC result release on time for finished product.
• To ensure QA personnel are compliance to Good Manufacturing Practices at all time.
• To execute parametric release for surgical products, ensure QA operation is fully utilize AiMS, participate in APS and also D365 ERP for QA/QC are on track for QA operation as per planned.
• Continue to support QA operation upstream (in process) daily activities as well when required.
• To drive improvement projects with Packing team to ensure packing operation are follow as per documented procedure, and release with good quality products.
• To support and coordinate incoming inspection for packaging material, and to conduct analysis, test method to assure the quality of incoming packing material prior supply to packing process.
• Contributes to the development and implementation of product test plans including Verification and Validation of products and processes.
• Supports development and implementation of Quality Function Deployment (QFD), Process Risk Analysis (PRA) and Control Plan for process/product in manufacturing environment
• Performs standard quality engineering reviews of design documentation for compliance with stated requirements, including supplier quality and company quality records
• Plans and conducts the analysis, inspection, design, tests, and/or integration of test methods to assure the quality of assigned products or components.
• Develops test methods and participates in the assessment of returned products, incoming, in-process and final test/inspection.
• Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes.
• Coordinates the documentation review, inspection workflow, training, problem solving and calibration of measuring and monitoring instruments.
• Advises on changes and their implementation and provides training, tools, and techniques to enable others to achieve quality
• Participates in the non-conformance reporting system, driving timely disposition and closure. Leads and/or participates in MRB meetings. Identify non-conformance trends and develop and administer technical investigation and corrective action programs to resolve recurring quality problems.
• Contributes to product safety, product quality, and customer satisfaction related decisions - data-based and risk-assessment-based decisions.
• Leads or participates and supports internal and external supplier audits and inspections
• Develops improvement plans and tracks quality performance
• Monitors and advises on how the product quality is performing and publishes data and reports regarding the effectiveness of the quality management system in achieving the product performance goals

What Will You Bring?

• Degree in Science (Material, Polymers, Bio Medical, Engineering, Chemistry or Quality Management System).

• Minimum 2 to 5 years’ experience as a Quality Engineer in the medical device industry or other related industries
• Medical Device Quality System Knowledge Including 21 CFR Part 820 (QSR), ISO 13485,
  ISO 9001 and Medical Device Regulation (MDR)
• Experience participating in internal and external audits (e.g., FDA, Notified Body, Customer
  and Supplier)
• A Certified Quality Engineer or Certified Quality Auditor will be an added advantage
• Excellent written and oral communication skills
• Prior medical device experience, or other regulated industry
• Ability to formulate responses to common inquiries or complaints from customers.
• Have good understanding of the Quality Assurance functions and its related disciplines.
• Decision making ability, work independently and proactively.