JOB DETAILS

JOB DETAIL

- Lead to overall Quality Requirement for Quality Control such as statistic process control, incoming In process final inspection, NC and customer complaint analysis.
- Execution of Quality Control activities related to CQ inspection included oversight product quality of rework and release.
- This role also responsible as Quality Control site Subject Matter Expert (SME) on process tools for QC control inspection, ensuring robust process are always followed and monitored.
- Manage, Control and maintain physical, functional, biological and chemical testing and inspection. for raw material, in-process and finished product including maintain of quality control plan in according to regulatory and customer requirement
- Provide necessary training to direct subordinates.
- To have coordination with QA assistance manager to control and maintain document control system within organization (for example, batch records, sterilization reports, and any controlled documents etc.)
- Control and maintain of product specification to meet applicable regulatory and customer requirement.
- To have coordination with QA assistance manager for product’s shipment and QA release as well as product’s certificate for customers.
- To control and ensure that risk management for all of products and processes in the company is
available and effective documented following ISO 14971 current edition. Participant to process risk management review by FMEA or HACCP
- Review of method validation for physical including measuring equipment validation.
- To coordinate with Quality Supervisor to review and control of supplier including supplier evaluation.
- Support for special test when any request from Peter Surgical (France)
- To coordinate with QA engineer to analysis and take correction or corrective action support for
non-conformity or deviation on product or process
- Take the final disposition on non-conformity report based on the outcome from non-conformity review board on behalf of Quality Manager.
- Review and control of process and product monitoring

REQUIRED WORK EXPERIENCE

- Bachelor’s degree in science or Engineering.
- Minimum 8 years in QC or QA, especially in medical device or pharmaceutical product will be plus
- Able to use computer (excel, word, power point),
- Fluent in spoken and written in English.