About the role
AI summarisedMfg/Ops Quality Engineer 2 role at Illumina in Singapore - Woodlands - NorthTech.
BiotechOnsite
Key Responsibilities
- Provide quality engineering support throughout the product life cycle.
- Assist teams in determining issue resolutions using a risk-based approach for engineering and manufacturing functions.
- Drive activities in prevention, detection of defects at earliest phase of product design, continuous improvement & customer satisfaction.
- Drive product risk management activities and ensure quality and completeness of project design history files, validation packages, and change orders.
- Provide consultation to end users and process owners with regard to data collection, analysis and creation of reports.
- Identify areas and opportunities to improve quality system processes.
- Ensure product development and validation programs meet requirements of FDA and ISO.
- Participate in investigations and ensure CAPA findings, risks, recommendations, and outcomes are appropriate and are clearly documented and communicated.
- Trend, analyze, and report on quality data in order to improve product and process; develop recommendations based on data analysis.
Requirements
- Bachelor’s degree in Engineering, Science, or other related field (or equivalent combination of education and experience).
- 3+ years’ experience in quality assurance field, in a regulated environment.
- Demonstrated ability to accomplish goals while working across departments is required.