QA ENGINEER, SYSTEM AND AUDIT

JOB PURPOSE

1. Management of product quality release for compounding & ULTEM resin products.
2. Oversee operation matters in QA such RM Quality & FG certification.
3. Coordinate product compliance support and regulatory data support.
4. SAP/LIMS system QM data and batch data support.

JOB RESPONSIBILITIES

EHSS compliance & Legislations

• Participate actively in EHS.
• Administrate Operation Management System Element. Complete Documentation and Internal audit per schedule without miss.
• Responsible to drive 5S activities and housekeeping inspection in QA Lab. Ensure upkeep of lab conditions all time for visits.
• Ensure required risk assessments are completed and documented, risk reduced ALARP in Quality.
• Collaborate cross-functionally to Management of Change (MOC) policy.

Maintenance of production quality standards and documentation

• Responsible for QMS ISO9001:2015 Management. Coordinate Internal Audit schedule, meetings, control of risk register. Maintenance of Quality files, procedures, formulation & specification update in ECM/QA Portal & SAP system.
• Support testing and handling laboratory analytical instruments, such as tensile and impact machine, injection molding machine, HPLC, GC and Spectrophotometer, sample/reagents preparation using basic laboratory equipment such as pipettes, centrifuge machine, hotplates, fume hood etc.
• Responsible for measurement system reliability, coordinate routine instrument calibration, maintenance, and troubleshooting. Coordinate with area owners on method verification, troubleshooting and improvement as required.
• Analyse and interpret data statistically for facilitation of data-driven decision.
• Support UL Management - Audits, sample submission, results follow-up & actions without miss.
• Lead customer compliance audits and visits. Ensure relevant documentation are updated. Update customer checklists as and when requested by customer.
• Responsible to lead monthly process audits, internal rejects actions closure & related corrective action request system. Keeps management fully apprised of significant occurrences and trends that impact the quality of product or manufacturing operations.

Totalize Transfer Finished Good & Process Improvements and Special projects.

• Spearhead assigned P&E projects to meeting all projects deliverables in schedule, cost with safety.
• Upkeep Lab equipment & measurement system through regular PM, calibration to ensure no production down time due to testing equipment.
• Coordinate shift activities and support shift QC team in the daily operations.
• Focal point for MDRM setup and raise PR in SAP. Monitor lab cost.
• Support all functional task assigned by functional leader as and when business needs.

Sustainability.

• Support QA sustainability project.
• Active participation during regular QA meetings.
• Response to feedback on lab equipment, consumables, and spare parts.
• Maintain consistency and stock for QA items available.
• Organize QA training for the shift team when required.

EDUCATION/EXPERIENCE REQUIREMENTS

• Diploma or bachelor’s degree from a relevant discipline.
• A minimum of 3 years of relevant QA operation experience in plastics and chemical industry.
• Fundamentals of Engineering Plastics product Quality & color.
• Knowledge of Quality standards & test methods.
• Knowledge of quality tools such as RCCA, FMEA, 8D reporting.
• Strong critical thinking and problem-solving skills.
• Ability to manage projects and work in a team.
• Ability to work under pressure, prioritize workload and be systematic.
• Extensive knowledge of statistics and data analysis.
• Good communication and analytical skills.