Product Quality Engineer for instrument devices (IVD and RUO instruments):Complaint specialist:
- Retrieve complaints (manually and multiple sources), verify with complaint source to match spreadsheet generated (source of complaint has not failed the validation, hence required manual check from spreadsheet to source so as to ensure no complaint is missing and not entered into TW)
- Transfer and enter into TW (today only complaint entered into E1 is auto populated)
- Obtain/follow up with mail and calls on missing information and translated into English with complaint entry sources
- Perform impact assessment in TW
- Timeline critical for complaint received and log in TW, evaluate and closure.
Provide management with quality data:
- trends in product performance in meeting customer requirements by providing and monitoring of:
- Product quality trend and address product issues.
- Work with cross functional in evaluation and qualification of material and processes.
Lead product Quality:
- Lead process-related corrective and preventive actions (CAPA) to successful conclusion, including confirmation of effectiveness
- Build quality into products through active participation with cross functional team projects to supporting product release.
- Participate and complete in quality escalation issues.
- Lead PQT quality related meeting and provide timely updates to stakeholders.
- Evaluate product return and drive failure investigation.
Participate in the development and implementation of quality initiatives to address system inadequacies as well as to achieve continual quality improvement objectives.
Support plant-wide activities and special projects, as assigned. Supports company goals and objectives, policies and procedures in compliance with quality systems, cGMP and FDA regulations.