This position is responsible for Quality activities that measure, monitor, and improve Illumina’s compliance with the Quality System Regulations, Illumina Quality policies, FDA regulations and ISO standards as well as Illumina product quality for current operation and compliance objectives.
Responsibilities:
- Provides quality assurance support, review and approvals to areas of manufacturing operations, product development, or field/ product quality.
- Assignment may include but not limited to overseeing processes such as non-conformance, product quality issue, incoming and outgoing inspection, return material authorization, calibration and etc.To develop, drive and setup documentation, executing New Product Introduction (NPI), Product Transfer related tasks to ensure operation readiness for NPI/Transfer.
- Works closely with cross-functional teams to review and assess engineering change/qualification/validation plan/document, ensuring impact/risk/validation status of the manufacturing equipment/process and production line are taken into consideration.
- Ensures that facilities, equipment, materials, processes, procedures and product readiness to comply with cGMP practices
- Drive cross-functional teams to resolve operational quality issues.
- Constantly review quality control processes and drive improvements that can be implemented to improve product quality performances.
- Ensure the quality system meets customer, corporate, or internal requirements and any other related requirement within the Quality Management System.
- Interact with all personnel levels and departments to ensure full compliance with all FDA, ISO rules and regulations.
- Work in accordance with procedures and integrated program plans for achieving and maintaining the required level of product quality in preparation for FDA and ISO third party audits.
- Other such duties that may be determined by Management.
- May train new engineers and associates.
- Other such duties that may be determined by Management.
All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
Requirements:
- > 3 years of working experience in highly regulated manufacturing environment.
- Experience in wafer manufacturing process preferred, such as Pattern formation, Lithography/Etching process, wafer dicing or laser cutting.
- Experience in project transfer/NPI and product quality Knowledge.
- Strong knowledge of quality system, tools and methodology skills in statistical analysis including SPC.
- Strong analytical, problem-solving and decision-making skills
- An individual with CQE is preferred.
- Experience in medical device/ IVD is preferred
Competencies:
- Knowledge of FDA Quality System Regulations and/ or ISO 13485 Standards requirement.
- Experience with words processing and spreadsheets, charting, graphing tools and presentation tools.
- May have experience with electronic production life (PLM), enterprise resource planning tools (SAP) and etc.
- May have experience with statistical analysis packages, e.g., JMP, Minitab.
- Must be detailed oriented, well organized and able to work independently and good collaboration within teams.
Education:
- Bachelor’s degree in Bio-engineering, Chemistry Engineering or relevant.