Quality Specialist
5 days ago
- Support and assist Assistant / QA or Quality Manager in managing QMS improvement initiative across all departments and functions to ensure quality initiatives and quality plans are executed and maintained in full compliance with IATF requirements.
- This includes addressing issues from quality management oversight and helping the site management team to effectively execute the quality enhancement activities.
- Review batch release activities for production including but not limited to review of product grading records, analytical data, Certificate of Analysis (COA) and other documents as needed for consistency with applicable regulations and for compliance with Company Quality System. Approve these records when Assistant / QA or Quality Manager delegates accordingly.
- Ensure the promotion of awareness of Quality Policy, Quality Objectives and Customer Specific Requirements (CSR) throughout organization.
- Release, review and verify CAPA quality related issues (Raw Material, Finished Product, Shipment & Logistics issues) and ensure effectives of corrective actions. ETQ Administrator for CAPA and Document Control.
- Review and update CSR (Customer Specific Requirement) and ensure all company employee understand and conform to CSR by providing training and awareness.
- Generate and review IATF / ISO procedures and Quality related procedures / instructions.
- Generate & review Management of Change (MOC) for any change in critical parameters, raw material specification and finished product specification.
- Generate Non-Regular Work (NRW) that will impact quality.
- Drive CPK improvement, review control charts, MSA and GR&R and recommend improvement action.
- Drive FMEA and Control Plan generation and revision.
- Manage IATF Core Tools (PPAP, APQP) documentation and reports.
- Assist Assistant / QA or Quality Manager during plant audits (customer audit, external, internal and Supplier audit). Follow up completion of plant audit findings corrective / preventive actions
- Lead Auditor for IATF / ISO Internal Audit and report nonconformity and recommends opportunities for improvement.
- Support Assistant / QA or Quality Manager in handling customer complaint & investigation.
- To make judgments in solving variances and help production in resolving issues related to quality.
- Participates in R&D activities. Review Product Safety requirements from customers.
- Working experience in quality such as lab testing or in Quality Assurance department.
- Knowledge and understanding of ISO 9001, IATF 16949 or similar quality systems and experience in facing quality audits.
Wealth Management
CAPA
FMEA
Quality Management
Quality Assurance
Quality System
Site Management
ISO
Investigation
APQP
Auditor
ISO 9001
Audits
PPAP
Audit
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