Specialist, QA
Specialist, QA
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Job Description
Why Ansell
At Ansell we stay two steps ahead of workplace risk to deliver innovative safety solutions that enhance peoples 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 across industrial medical and consumer applications.
Discover more about our company our people and our values by visiting us at Ansell.
Ansell is looking for a QA Specialist to join our team in Cyberjaya.
In this position you will play a vital role in Carry out QA activities as assigned in supporting organizational goals. This position will be responsible for onsite /virtual product inspection /audit supplier audit product sample evaluation and side by side comparison and additional assignments such as multi-sources product evaluation and trending analysis COA review coordinating Change Control and implementation process and/or as assigned by QA Manager and/or QARA Director.
What benefits and opportunities does Ansell offer
Competitive compensation plan including a performance based annual incentive.
Flexible and hybrid work model.
A culture of belonging and inclusion collaboration thrives and everyone feels seen heard and empoweredacross our global community.
Ansell University LinkedIn Learning and Mentorship programs to develop professional and interpersonal skills.
Opportunities to advance and grow within the company through LinkedIn Learning and Mentorships.
What your role will be
1. Onsite /virtual product inspection /surveillance /audit:
a. Perform product inspections and Quality audits of Ansells Manufacturing Partners.
The duties include:
b. Perform onsite /virtual inspection and testing of finished product to ensure
conformance to the agreed specifications and maintain appropriate records.
c. The testing includes (but not limited to):
i. Water leak test
ii. Physical dimension measurements (length width thickness & weight)
iii. Physical properties measurements (Elongation Modulus Tensile Strength
Force at break)
iv. Visual inspection (glove and packaging)
v. Packaging & labelling Quality
vi. Packing quality
vii. Glove durability test
viii. White residue /IPA and Foaming test
ix. Container loading (as needed)
x. Ash (filler check) to be performed by SA lab
xi. Etc. (as assigned by QA Manager /Director from time to time)
d. Analyse test results of suppliers Certificate of Analysis
e. Prepare trending charts for routine monitoring & conduct comparison analysis
f. Analyse test results and trends and make comments and recommendations
g. Prepare inspection report and update quality dashboard
h. When necessary correlate localfactory test results with inhouse lab results and assist
in identifying and correcting unexplained data discrepancies
i. Identify production that deviates from historical trends even if it still is within
specification
j. Work onsite with Manufacturing Partners to correct product quality and/or
manufacturing process related issues including onsite verification of corrective
actions triggered from PQC/SCAR.
k. Work on special projects as needed
2. Supplier audit
a. Perform suppliers quality system audit and/or surveillance per ISO 9001 ISO13485
US FDA 21 CFR 820 Quality System Regulation and Canada Medical Device Regulation
SOR/98-282.
b. Work with Manufacturing Partners to correct product quality and/or manufacturing
process related issues including onsite verification of corrective actions triggered
from supplier audit finding.
3. Sample Evaluation
Assist in the product evaluation /qualification and set-up of new products and/or new
suppliers. Perform product testing provide side by side product comparison reports provide
analysis comments /recommendations and highlighting product performance variation of new sourcing options or new potential products.
4. Sample Evaluation multi-sources product
Assist in the product evaluation comparison and trending analysis of multi-sources products. Perform product testing provide side by side product comparison reports provide analysis comments /recommendations and highlighting product variation if any.
5. Change Control
Coordinate suppliers change request by initiating Change Control record in TWD coordinate with PPM RA QA and MP to ensure the required aspects are carried out reviewed and approved prior to implementation. Compile the necessary supporting test reports and documentation for CRB review /approval and carry out verification /effectiveness check of the change.
6. COA review
To review Certificate of Analysis (COA) as assigned to ensure the shipment goods conforms to the product specification. Sign off COA and report OOS/OOC (if any) to QAM.
7. Other QA task(s) as assigned by QA Manager and/or Director.
What will you bring to Ansell
Bachelor Degree or equivalent collage education (in chemistry /polymer science) preferred; High School education accepted with sufficient work experience in QA RA and QMS management.
Working experience in Quality Management System (manufacturing) ISO9001 ISO13485 and MDSAP US FDA QSR and CFR 21 and Supplier QARA Management Systems.
Working experience in Medical Device QARA i.e. EN MDR and PPE regulations all regional /country MD regulations including gloves standards ie ASTM EN ISO JIS TGA GB & etc.
Working experience in Glove manufacturing /Glove R&D preferred.
Communicate fluently (oral & written) in English (required). Bahasa Malaysia (preferred) Chinese / Mandarin (preferred)
Good written English with technical writing / reporting skills
High Computer Literacy specifically in MS Excel (particularly data trending and analysis) MS Word MS PowerPoint MS Access experience also preferred
Analytical thinking and problem solving ability
Ability to analyse & make comments /recommendations
Able to work independently with minimal supervision
Flexible in job rotation
Join us to lead the world to a safer future apply today!
Equal Opportunity Employer
Ansell is committed to a policy of Equal Employment Opportunity and will not discriminate against an applicant or employee based on race color religion creed national origin or ancestry sex age physical or mental disability veteran or military status genetic information marital status parental status or any other legally recognized protected basis under federal state or local law. The information collected by this application is solely to determine suitability for employment verify identity and maintain employment statistics on applicants.
Our Commitment to Belonging and Inclusion
Ansells vision is about creating safe spaces where all perspectives are valued alongside individual contributions. When we say that everyone deserves to belong feel included and empowered at work. its not just words. We want applicants to know that we endeavor to create an inclusive environment that will consider all regardless of age gender background disability veteran status or experience alone! Its what drives Ansell as an organization towards a workforce that reflects the communities in which we operate its what drives us to serve our customers and stakeholders with pride and its what differentiates Ansell.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
