Specialist

Job Description - Specialist, QA (30010870)

Job Description

Specialist, QA-(30010870)

Description

Why Ansell?

At Ansell, we stay two steps ahead of workplace risk to deliver innovative safety solutions that enhance people's 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 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.

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 empowered—across 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 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 analysis

f. 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 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 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 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, !

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

Ansell’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.