Quality Operations Engineer
About The Position
The Quality Operations Engineer designs, implements, and maintains quality master data to support processing materials into partially finished or finished products and transacting them in the ERP system. This role is responsible for planning, implementing, improving, and managing compliance of quality master data, material movement, acceptance, and control processes. The engineer assesses and performs these processes in alignment with internal and external safety, quality, and regulatory standards for worldwide distribution. They perform analysis of reports and ERP/production data to identify trends and recommend updates or changes to quality standards and procedures. The position may also assure compliance to in-house and/or external specifications and standards such as GLP, GMP, ISO, and Six Sigma.
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)
- eligible roles may receive equity as part of the compensation package
- inclusive environment where employees feel valued and empowered to contribute to our mission
- zero-net gap in pay, regardless of gender, ethnicity, or race
- Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and offer opportunities to engage in social responsibility
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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
