Quality Operations Engineer

Illumina • San Diego, CA

20h

About The Position

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.

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

Nice To Haves

• Experience with MS Power Platform and Copilot
• Proficient in SQL and Python
• Working knowledge of Quality Management Systems

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.

Benefits

• access to genomics sequencing
• family planning
• health/dental/vision
• retirement benefits
• paid time off
• variable cash programs (bonus or commission)
• equity as part of the compensation package
• inclusive environment where employees feel valued and empowered to contribute to our mission
• Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and offer opportunities to engage in social responsibility

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: No Education Listed
• Number of Employees: 1,001-5,000 employees