QA Analyst

**QA Analyst (Microbiologist)**
**-**
**(**
**30005034**
**)**

**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.

**GENERAL SUMMARY OF POSITION**

Analyst, QA (Microbiologist) 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. To review, plan, coordinate and organize the schedule of overall activities for Microbiological Laboratory according to internal and external standards.

2. To manage and supervise microbiological laboratory personnel on daily work activities to ensure sterility testing, bacterial endotoxin testing and bioburden test are carry out according to the documented procedure, test method and work instruction.

3. To prepare data compilation, monitor trend analysis, conduct investigation related to environmental testing, microbiological and sterilization failures, and handling laboratory out of specification result.

4. To ensure microbiological test release on time for medical devices.

5. To ensure laboratory personnel are compliance to Good Laboratory Practices at all time.

6. To support physical and chemistry laboratory daily activities as well when required.

7. Understand the Company’s Quality Policy, Environmental Policy, Occupational Safety & Health Policy, etc.

8. To understand the implications of improper job performance and the need for quality work.

9. 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.

10. To understand and adhere to FDA QSR, ISO 9001, EN ISO 13485, ISO 11137, ISO 17025 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.

11. To coordinate, review and update timely the quality manual, quality system specifications, standard operating procedures, microbiological test sampling plan and other relevant documents.

12. Contributes to the development and implementation of product test plans including Verification and Validation of products, processes and sterilization validation activity.

13. Supports development and implementation of Quality Function Deployment (QFD), Process Risk Analysis (PRA) and Control Plan for process/product in manufacturing environment

14. Performs standard quality engineering reviews of design documentation for compliance with stated requirements, including supplier quality and company quality records

15. Plans and conducts the analysis, inspection, design, tests, and/or integration of test methods to assure the quality of assigned products or components.

16. Develops test methods and participates in the assessment of returned products, incoming, in-process and final test/inspection.

17. Coordinates the documentation review, inspection workflow, training, problem solving and calibration of measuring and monitoring instruments.

18. Advises on changes and their implementation and provides training, tools, and techniques to enable others to achieve quality

19. Utilizes statistical analysis techniques to determine product acceptance, evaluate process capabilities, and develop statistically sound tolerance limits

20. 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.

21. Supports the 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.

22. Contributes to product safety