QA Outsourced Product Quality Specialist

**QA Outsourced Product Quality Specialist** **-** **(**30010148**)**

**Description**

**Why Ansell?**

Ansell is looking for a QA Outsource Product QA Specialist to join our team in Cyberjaya.

In this role, you will 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, including a performance-based annual incentives
- Flexible and hybrid schedule
- An inclusive and collaborative environment that values diversity and fosters an international culture
- Ansell University programs to develop professional and interpersonal skills
- Opportunities to advance and grow within the company

**What your role will be?**

Collaborating with our cross functional teams, and reporting to the Manager QA, you will have the opportunity to:
**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):

- Water leak test
- Physical dimension measurements (length, width, thickness & weight)
- Physical properties measurements (Elongation, Modulus, Tensile Strength, Force at break)
- Visual inspection (glove and packaging)
- Packaging & labelling Quality
- Packing quality
- Glove durability test
- White residue /IPA and Foaming test
- Container loading (as needed)
- Ash (filler check) to be performed by SA lab
- 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.** **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.

**5.** **Product Specification**

a. Assist QA Manager in establishing, documenting and maintaining product specifications (PS) for outsource HGBU finished products. And assist QA Manager in capturing change /update per Standards (i.e. ASTM, EN, ISO, JIS, GB & etc. - product /inspection requirement, acceptance criteria, sampling plan, test methods and etc.) from time to time, and update PS accordingly.

b. Liaise with marketing, technical, GBU, regulatory, artwork team for the approvals of product specification to ensure compliance to regulatory and customer requirement.

**6.** **Technical /Product Information and Support**

a. As assigned by QA Manager, to compile and maintain suppliers’ product technical files for medical products, to support regional QARA and Scientific Affairs in MDR technical file maintenance per EU MDR and MDSAP.

b. As assigned by QA Manager, to compile and maintain suppliers’ product technical files for non-medical products, to support regional QARA per EU PPE requirement and per Ansell req