Specialist, QA
- Cyberjaya, Selangor
- Permanent
- Full-time
a. Perform product inspections and Quality audits of Ansell’s 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 supplier’s Certificate of Analysis
e. Prepare trending charts for routine monitoring & conduct comparison analysisf. Analyse test results and trends, and make comments and recommendations
g. Prepare inspection report and update quality dashboard
h. When necessary correlate local\factory 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 needed2. 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 i,e, 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 skillsHigh Computer Literacy, specifically in MS Excel (particularly data trending and analysis), MS Word, MS PowerPoint, MS Access experience also preferredAnalytical thinking and problem solving abilityAbility to analyse & make comments /recommendationsAble to work independently with minimal supervisionFlexible in job rotationJoin us to lead the world to a safer future, !Equal Opportunity EmployerAnsell 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 InclusionAnsell’s 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., it's 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! It’s what drives Ansell as an organization towards a workforce that reflects the communities in which we operate, it’s what drives us to serve our customers and stakeholders with pride, and it’s what differentiates Ansell.