What if the work you did every day could impact the lives of people you know? Or all of humanity?
At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.
Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.
Position Summary:
Designs, implements and maintains quality master data to support processing materials into partially finished or finished products and transacting them in the ERP system. Responsible for planning, implementing, improving, and managing compliance of quality master data, material movement, acceptance, and control processes. Assesses and performs these processes in alignment with internal and external safety, quality and regulatory standards requirements for worldwide distribution. Performs analysis of reports and ERP/ production data to identify trends and recommend updates or changes to quality standards and procedures when necessary. May assure compliance to in-house and/or external specifications and standards (i.e. GLP, GMP, ISO, Six Sigma).
Changes to individual responsibilities may occur due to business needs and other related duties may be assigned.
Responsibilities:
- Trend, analyze, and report on product quality data, SAP master data, and transactional material movement/ containment/ disposition data in order to improve product, process, and material infrastructure; develop recommendations from that analysis.
- Leverage knowledge of Quality processes to interrogate QMS data for ad hoc analyses, problem solving, and continuous improvement.
- Drive improvements to key material and ERP system processes such as unkitting/ salvage, recharge/ recalibration, sample request, containment/ disposition, date extension, MICs, RMA, batch data updates, etc.
- Build dashboard and efficiency infrastructure to help support Batch Record Review and Incoming Quality Control functions.
- Support the testing and debugging of dashboards detailing Quality master data and material transactions to ensure accuracy and adherence to user requirements.
- Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion.
- Collaborate and build relationships with counterparts and cross-functional teams at other Illumina sites.
- Ensure adequacy of non-conformances and CAPA records, investigations, and corrective actions.
- Become familiar with the applicable technology to facilitate participation in technical discussions and risk-based decision making.
- Review change requests/notices/approvals for compliance to change requirements outlined in applicable WIs/Procedures.
- Develop and execute strategies to close gaps in an efficient, technical, and compliant manner.
- Coordinate issue resolution using a risk-based approach; coordinate projects and continuous improvement efforts requiring inputs from diverse teams.
- Ensure manufacturing processes meet requirements of FDA and ISO.
- Other activities as assigned.
Requirements:
0-2 years experience in quality assurance field in a regulated environment; direct experience working in in-vitro diagnostic manufacturing preferred
Demonstrated experience and capability with MS Excel and data visualization tools such as Tableau or Power BI.
Proven ability to work in ERP systems, SAP preferred
Proficient in use of Microsoft Office (Word, Excel, Outlook, PowerPoint
Preferred Skills:
Experience with MS Power Platform and Copilot
Proficient in SQL and Python
Working knowledge of Quality Management Systems
Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.
The estimated base salary range for the Quality Operations Engineer role based in the United States of America is: $62,900 - $94,300. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. The range reflects long‑term growth in the role. Most candidates are hired between the minimum and middle of the range. Placement depends on experience, skills, location, and internal equity. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits as innovative as our work, including access to genomics sequencing, family planning, health/dental/vision, retirement benefits, and paid time off.
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 accommodations@illumina.com. 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.