Analyst, QA - ( 30006001 )
Description


Ansell is a leading global provider of protection solutions. Our company designs, develops and manufactures a wide range of protection solutions that meet the ever-changing needs and demands of our markets and industries. Protection is our primary concern as millions of people around the world depend on Ansell in their professional and personal lives.

Our vision is to create a world where people can enjoy optimal protection against the risk they are exposed to. Whether at work or during their leisure time, people require the right protection for the right application. After all, what better guarantee is there than increased safety, security and productivity than through adequate protection.
GENERAL SUMMARY OF POSITION
Analyst, QA (QA Operation) develops, 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.
RESPONSIBILITIES & SPECIFIC ACCOUNTABILITIES
1. Understand the Company\xe2\x80\x99s Quality Policy, Environmental Policy, Occupational Safety & Health Policy, etc.
2. To understand the implications of improper job performance and the need for quality work.
3. 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.
4. 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.
5. As coordinator for complaints management team for investigating, determining root cause and ultimate resolution of product failures. Work as a team with all relevant departments to evaluate actual of potential product failures and update risk management files as needed.
6. 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.
7. To manage all the NCMR, CAPA and Complaint Management in TrackWise Digital (TWD) system.
8. 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.
9. To coordinate and update timely the quality manual, quality system specifications, standard operating procedures and other relevant documents.
10. Contributes to the development and implementation of product test plans including Verification and Validation of products and processes.
11. Supports development and implementation of Quality Function Deployment (QFD), Process Risk Analysis (PRA) and Control Plan for process/product in manufacturing environment.
12. Performs standard quality engineering reviews of design documentation for compliance with stated requirements, including supplier quality and company quality records.
13. Plans and conducts the analysis, inspection, design, tests, and/or integration of test methods to assure the quality of assigned products or components.
14. Develops test methods and participates in the assessment of returned products, incoming, in-process and final test/inspection.
15. Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes.
16. Coordinates the documentation review, inspection workflow, training, problem solving and calibration of measuring and monitoring instruments.
17. Advises on changes and their implementation and provides training, tools, and techniques to enable others to achieve quality.
18. Utilizes statistical analysis techniques to determine product acceptance and AQL sampling plans, evaluate process capabilities, and develop statistically sound tolerance limits.
19. 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.
20. Contributes to product safety, product quality, and customer satisfaction related decisions - data-based and risk-assessment-based decisions.
21. Leads or participates and supports internal and external supplier audits and inspections.
22. Develops improvement plans and tracks quality performance.
23. 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.
24. Maintain technical file for all products manufactured, support regional RA team with technical file documentation.
KEY POSITION REQUIREMENTS
Education: \xe2\x80\xa2 Degree in Science (Material, Polymers, Bio Medical, Engineering, Chemistry or Quality Management System).


Job Experience:

• Minimum 2 to 5 years\xe2\x80\x99 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. Knowledge and Skills

\xe2\x80\xa2 Excellent written and oral communication skills. \xe2\x80\xa2 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.

Desirable Job Competencies

• Works independently as well as within a team, with guidance in only the most complex situations.

• Strong leadership qualities, self-motivated and able to lead a team of operators in meeting daily target.

• Mature and analytical with strong leadership qualities and people management and interactive skills.

• Excellent communication, analytical and interpersonal skills with good leadership qualities.

Primary Location : Malaysia-Melaka-Air Keroh
Work Locations : MY Melaka Air Keroh Lot 80 Lot 80 Air Keroh Industrial Estate Air Keroh 75450
Job : Quality
Organization : Healthcare GBU
Schedule : Full-time
Employee Status : Regular
Job Type : Standard
Job Level : Analyst
Job Posting : Apr 3, 2023, 11:10:37 PM