Why Ansell
Ansell is a world leader in providing superior health and safety protection solutions that enhance human well-being. The world's need for better protection never stops, so Ansell is constantly researching, developing and investing to manufacture and distribute cutting edge product innovation and technology, marketed under well-known brands that customers trust. Operating in two main business segments, Industrial and Healthcare, Ansell is the market leader that continues to grow, employing 14,000 people worldwide.
For more information about our Company, our People and our Values, please follow the link https://www.ansell.com
Ansell is looking for Specialist QA lab to be based in Seremban, Malaysia. This position is responsible to Support Associate Manager (QMS & RA) to ensure compliance of Quality Management System (QMS) and Regulatory Affairs (RA) for medical gloves in line with applicable standards and regulations. He/She will report the performance of the quality system to management for review and ensure that effective and preventive actions are taken to maintain and improve the quality system as well as product quality. The primary function is to lead and maintain QMS and RA functions to ensure product compliance, regulatory approval, and audit readiness for medical gloves across global markets.
What you can expect from Ansell
- Work for a world leader in the health and safety protection solutions industry.
- A secure workplace with competitive remuneration and annual bonus based on own and company performance.
- Inclusive, collaborative, and supportive work atmosphere.
- A diverse and international work environment.
What your role will be in details
Reporting to the Assistant QA Manager, you will:
- Understand the Company's Quality Policy, Environmental Policy, Occupational Safety & Health Policy, that relate to Quality Management System.
- To understand and adhere to FDA QMSR, ISO 9001, EN ISO 13485 and regulatory standards and requirements such as JPMDA, 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 system specifications, standard operating procedures, test methods, etc. with other departments
- To maintain document and records effectively and properly in the QA document center and archives
- To create and maintain the standardize format of document and record layout for the company documentation.
- To be the guardian for the company quality system documentation, to ensure no unauthorized use of the company documents.
- To manage and maintain latest standards, specifications, procedures, and records pertaining to standards and regulatory requirements and quality system.
- To manage well the product registration and other related tasks relating to traceability and product related matters.
- Coordinate external and internal audits and recommend appropriate corrective actions to ensure QMS compliant. To compile overall audit findings and prepare Audit Summary Report and to follow up on the closure of the action items proposed for the respective findings
- Conduct gap analysis for QMS and RA and implement necessary improvements.
- Liaise with regulatory authorities, notified bodies, and certification bodies.
- Review product specifications and ensure alignment with standard and regulatory requirements.
- Provide QA/RA guidance during product development and changes.
- Product Registration and Renewal - to prepare, compile and provide registration or renewal documents to regional RA
- Maintain technical file for all products manufactured, support regional RA team with technical file documentation
- To ensure labeling and claims comply with regulatory requirements.
- To manage the company's document control system effectively and securely per standards and regulatory requirements.
- Conduct or Support training on QMS and regulatory requirements.
- Identify opportunities to improve QMS processes and efficiency.
- Drive digital transformation of QMS and RA processes to improve efficiency, compliance, and traceability
- Ensure compliance culture across the organization.
- Assist Assoc Manager (QMS & RA) in managing regulatory transitions and work closely on implementation of new or revised regulations to ensure timely compliance and smooth transition.
What will you bring
- Bachelor's Degree in Chemistry, Polymer Science, Rubber Technology, Chemical Engineering or its equivalent
- Good knowledge of ISO 9001:2015 and ISO 13485:2016
- Detail-oriented with strong documentation skills.
- Exposure to multiple regulatory markets (EU, US, ASEAN).
- Good communication and interpersonal skills
- Good written and spoken English and ability to communicate in a language other than English and Malay or a foreign language will be an added advantage.
- Well organized and with capability to make good reporting.
- 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.
- Possess foundation level knowledge of glove dipping processes and on product defectives and quality.
- Possess a continuous improvement mindset.
- Possess knowledge in analytical techniques, good knowledge in relevant computer software such as SPC software etc.
- Has good understanding of safety, health and environment practices, good manufacturing practices.
- Good work & time management skills and applies good project management skills.
- Competent in systematic and statistical data analysis, as well as presentation of results.
- Good understanding of Quality Management Systems, particularly ISO 13485.
