Position Summary:
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.
Position Responsibilities:
Execute New Product Introduction (NPI) and Product Transfer related tasks to ensure operation readiness for NPI/Transfer, including creation and setup of related documentation.
Responsible for ensuring the dependability and performance of systems and products throughout their lifecycle, applying engineering principles and techniques to design, test, and maintain reliable systems.
Identify product performance potential risks, performing root cause analysis of failures, and implementing effective solutions to mitigate these risks.
Work closely with cross-functional teams to ensure that reliability is built into products from the early stages of development through to their operational use.
Work closely with cross-functional teams to review and assess engineering change/qualification/validation documentation, ensuring impact/risk/validation status of the manufacturing equipment/process and production line are taken into consideration.
Design methods and procedures for inspecting, testing and evaluating the precision and accuracy of production processes, production equipment and finished products.
Perform analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary.
Constantly review quality control processes and drive improvements that can be implemented to improve product quality performance to enhance customer satisfaction, reduce maintenance costs, and improve overall product performance.
Provide 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, etc.
Ensure facilities, equipment, materials, processes, procedures and product readiness to comply with cGMP practices.
Interact with various personnel levels and departments to ensure compliance with FDA, MDSAP, IVDR, ISO rules and regulations, including audit/inspection readiness.
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 as determined by Management.
Position Requirements:
Bachelor’s degree in Bio-engineering, Chemistry Engineering or relevant field.
Typically requires a minimum of 5 years of related experience with a Bachelor’s degree; or 3 years and a Master’s degree; or a PhD without experience; or equivalent work experience.
Minimum 3 years of working experience in highly regulated manufacturing environment, with knowledge of FDA Quality System Regulations and/or ISO 13485 Standards.
Experience in project transfer/NPI and product quality knowledge.
Strong knowledge of quality system, tools and methodology skills in statistical analysis including Statistical Process Control (SPC).
Strong analytical, problem-solving and decision-making skills.
Detailed oriented, well organized and able to work independently and collaboratively.
Certified Quality Engineer (CQE) certification is highly advantageous.
Experience in medical device/IVD is preferred.
Experience with words processing, spreadsheets, charting, graphing, and presentation tools.
May have experience with electronic enterprise systems such as Product Lifecycle Management (PLM), Enterprise Resource Planning (e.g. SAP), etc.
May have experience with statistical analysis packages, e.g., JMP, Minitab.
We are a company deeply rooted in belonging, promoting an inclusive environment where employees feel valued and empowered to contribute to our mission. Built on a strong foundation, Illumina has always prioritized openness, collaboration, and seeking alternative perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and offer opportunities to engage in social responsibility. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. Illumina conducts background checks on applicants for whom a conditional offer of employment has been made. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable local, state, and federal laws. Background check results may potentially result in the withdrawal of a conditional offer of employment. The background check process and any decisions made as a result shall be made in accordance with all applicable local, state, and federal laws. Illumina prohibits the use of generative artificial intelligence (AI) in the application and interview process. If you require accommodation to complete the application or interview process, please contact [email protected]. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf. The position will be posted until a final candidate is selected or the requisition has a sufficient number of qualified applicants. This role is not eligible for visa sponsorship.
