- Onsite /virtual product inspection /surveillance /audit:
- Perform onsite /virtual inspection and testing of finished product to ensure conformance to the agreed specifications, and maintain appropriate records.
- The testing includes (but not limited to):
- Water leak test
- Packaging & labelling Quality
- Ash (filler check) to be performed by SA lab
- Analyse test results of supplier's Certificate of Analysis
- Prepare trending charts for routine monitoring & conduct comparison analysis
- Analyse test results and trends, and make comments and recommendations
- Prepare inspection report and update quality dashboard
- When necessary correlate localfactory test results with inhouse lab results and assist in identifying and correcting unexplained data discrepancies
- Identify production that deviates from historical trends, even if it still is within specification
- 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.
- Work on special projects as needed
- Supplier audit
- 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.
- 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.
- Sample Evaluation
- Sample Evaluation – multi-sources product
- Change Control
- COA review
- Other QA task(s) as assigned by QA Manager and/or Director.
- Minimum 3 years of working experience in compliance and auditing background. (Quality assurance is preferred.)
- Fresh graduates are welcome to apply.
- Computer literate and familiar with MS office application software e.g words, Excel, Powder point and other software like Adobe.
- Hands-on experience with Quality System Standards is preferred.
- Gloves manufacturing processes background is advantaged.
- Good knowledge in ISO 9001 & ISO 13485 Quality System requirement.
- Travel with flexible schedule and short timeline notification whenever necessary.
- Be accurate, precise and reliable in evaluating the testing data against established product specification.
- Good written and oral communication skill.
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Assoc Specialist, Quality Assurance - Malaysia, Selangor - Ansell
Description
General Summary Of The PositionThis 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, as assigned by QA Manager and/or QARA Director.
What would your role look like
Reporting to Sr Manager or Director, you will be:
iii. Physical properties measurements (Elongation, Modulus, Tensile Strength, Force at break)
iv. Visual inspection (glove and packaging)
vii. Glove durability test
viii. White residue /IPA and Foaming test
ix. Container loading (as needed)
Malaysia-Selangor-Cyberjaya
Work Locations
MY Selangor Cyberjaya Prima 6 Prima Avenue Block 3512
Job
Quality
Organization
Global Product & Marketing
Schedule
Full-time
Job Type
Standard
Job Level
Analyst
Travel
Yes, 75 % of the Time
Job Posting
Feb 16, 2024, 6:21:27 AM