Quality Operations Engineer

San Diego, CA - USA

Monthly Salary: $ 61700 - 92500

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

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.

Responsibilities:

- Ensures 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.

- Ensure manufacturing processes meet requirements of FDA and ISO.

- Trend analyze and report on quality data in order to improve product and process; develop recommendations based on data analysis.

- Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion.

- Collaborate with counterparts and cross-functional teams at other Illumina sites.

- 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
Knowledge and experience applying quality regulations and standards (21CFR 820 ISO 13485 ISO 14971 IVDD)
Knowledge and experience with instituting quality controls in an ERP system SAP preferred
Highly effective communication facilitation and negotiation skills
Adaptable to fast-paced dynamic work environment with shifting demands

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: $61700 - $92500. 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 individuals 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 To learn more visit: 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.

What if the work you did every day could impact the lives of people you know Or all of humanityAt 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 t...