Position Summary:
Designs, implements and maintains quality assurance protocols and methods for processing materials into partially finished or finished products. Responsible for planning, implementing and managing compliance of manufacturing and production processes with internal and external safety, quality and regulatory standards requirements for worldwide distribution. Designs methods and procedures for inspecting, testing and evaluating the precision and accuracy of production processes, production equipment and finished products. Performs analysis of reports and 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 quality data (metrics and KPIs) in order to improve product and process; develop recommendations from that analysis.
Leverage knowledge of Quality processes to interrogate QMS data for ad hoc analyses, problem solving, and continuous improvement.
Support the testing and debugging of dashboards detailing Quality metrics 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 equipment onboarding, calibration and preventative maintenance tickets and identify potential gaps for GMP compliance.
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.
Proficient in use of Microsoft Office (Word, Excel, Outlook, PowerPoint
Preferred Skills:
Experience with MS Power Platform and Copilot
Proficient in SQL and Python
Proven ability to work in SAP
Working knowledge of Quality Management Systems
Comfortable with generating and/or executing test cases for dashboard visualizations
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: $61,700 - $92,500. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location where the role is to be performed, internal equity, and alignment with market data. 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 [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.
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