Talent.com
Quality Operations Engineer
Quality Operations EngineerIllumina • San Diego, California, USA
Quality Operations Engineer

Quality Operations Engineer

Illumina • San Diego, California, USA
9 days ago
Job type
  • Full-time
Job description

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.

    Key Skills

    Change Management,Software Deployment,Cloud Infrastructure,High Availability,IaaS,Firewall,Linux,Middleware,Jboss,Network Architecture,Scripting,Technical Support

    Employment Type : Full-Time

    Experience : years

    Vacancy : 1

    Monthly Salary Salary : 61700 - 92500

    Create a job alert for this search

    Quality Engineer • San Diego, California, USA

    Related jobs
    Quality Engineer

    Quality Engineer

    Abbott • San Diego, California, USA
    Full-time
    Abbott is a global healthcare leader that helps people live more fully at all stages of life.Our portfolio of life-changing technologies spans the spectrum of healthcare with leading businesses and...Show more
    Last updated: 11 days ago • Promoted
    Continuous improvement Engineer-Otay

    Continuous improvement Engineer-Otay

    Turbo Tecnología de Reparaciones, S.A. de C.V. • Tijuana, Baja California, Mexico
    Assist in production operations to drive improvement in manufacturing efficiencies by utilizing continuous improvement techniques. Be responsible for managing and leading continuous improvement proj...Show more
    Last updated: 30+ days ago • Promoted
    Quality Engineer

    Quality Engineer

    Autoliv Mexico • Tijuana
    Quick Apply
    Autoliv es el líder mundial en sistemas de seguridad automotriz.A través de nuestras empresas del grupo, desarrollamos, fabricamos y comercializamos sistemas de protección, como airbags, cinturones...Show more
    Last updated: 30+ days ago
    Senior Quality Engineer, Design

    Senior Quality Engineer, Design

    ICU Medical • Tijuana, Baja California, Mexico
    Direct message the job poster from ICU Medical.Human Resources Professional, SHRM-CP, HRBP.Provide quality support for ICU Medical Product and Development and design changes.Quality Engineer will b...Show more
    Last updated: 30+ days ago • Promoted
    Quality Management System Engineer

    Quality Management System Engineer

    LUXSHARE • Tijuana, Baja California, Mexico
    Ensure compliance with the Quality Management System, in accordance with Luxshare QMS, applicable worldwide standards, for example IATF 16949 and ISO 9001. Assist with implementing and maintaining a...Show more
    Last updated: 14 days ago • Promoted
    Senior Quality Engineer

    Senior Quality Engineer

    ClickUp • San Diego, California, USA
    Full-time
    At ClickUp were not just building software.Were architecting the future of work! In a world overwhelmed by work sprawl we saw a better way. Thats why we created the first truly converged AI workspac...Show more
    Last updated: 30+ days ago • Promoted
    Specialist 2, Quality Systems

    Specialist 2, Quality Systems

    Halozyme • San Diego, California, USA
    Full-time
    Save time and apply through your LinkedIn account.Click the button and your LinkedIn profile will be imported into our site. In order to move forward you will need to create an account.Your passwor...Show more
    Last updated: 13 days ago • Promoted
    Senior Supplier Quality Engineer

    Senior Supplier Quality Engineer

    Bourns de Mexico, S. de R.L. de C.V. • Tijuana, Baja California, Mexico
    Responsable de manejar los problemas de proveedores en el ambiente de manufactura, proporcionando soporte oportuno en cuestiones de calidad a producción y asegurando la integridad de la materia pri...Show more
    Last updated: 30+ days ago • Promoted
    Manufacturing Operations Engineer

    Manufacturing Operations Engineer

    Revvity • San Diego, California, USA
    Full-time +1
    Manufacturing Operations Engineer.Revvity is a developer and provider of end-to-end solutions designed to help scientists researchers and clinicians solve the worlds greatest health challenges.We p...Show more
    Last updated: 19 days ago • Promoted
    Senior Supplier Quality Engineer

    Senior Supplier Quality Engineer

    Outset Medical • Tijuana, Baja California, Mexico
    Join us for an enriching journey with Outset, a trailblazing medical device company that is revolutionizing the field of dialysis. Our focus is to create one high performing team, obsessed with prog...Show more
    Last updated: 30+ days ago • Promoted
    Operations Engineer

    Operations Engineer

    TradeJobsWorkForce • 92129 San Diego, CA, US
    Full-time
    Operations Engineer Job Duties : Identifies operational problems by observing and studying system func...Show more
    Last updated: 30+ days ago • Promoted
    Specialist I, Quality Systems

    Specialist I, Quality Systems

    Werfen • San Diego, California, USA
    Full-time +1
    The Quality Systems (QS) Specialist I.Quality Management System (QMS) which helps to ensure compliance.GMP requirements FDA & ISO standards and other regulations as they pertain to the QMS.The ...Show more
    Last updated: 19 days ago • Promoted
    Quality Assurance Engineer

    Quality Assurance Engineer

    KYOCERA External • San Diego, California, USA
    Full-time
    With nearly 80000 employees globally Kyocera is a leading manufacturer of high-tech ceramics in various industries including aerospace automotive Medical applications and semiconductor processing.O...Show more
    Last updated: 15 days ago • Promoted
    Quality Systems Engineer II

    Quality Systems Engineer II

    Haemonetics Software Solutions • Tijuana, Baja California, Mexico
    Quality Systems Engineer II page is loaded## Quality Systems Engineer IIlocations : Tijuana, Mexicotime type : Full timeposted on : Posted Todayjob requisition id : R9969We are constantly looki...Show more
    Last updated: 30+ days ago • Promoted
    Quality Systems Engineer

    Quality Systems Engineer

    Ignite Human Capital • San Diego, CA, US
    Full-time
    Quick Apply
    The Quality Systems Engineer plays a critical role in maintaining and improving the Quality Management System (QMS) in compliance with applicable regulatory requirements (e.MDSAP, EU MDR 2017 / 745, ...Show more
    Last updated: 2 days ago
    Quality Engineer Hi Rel

    Quality Engineer Hi Rel

    T2S Solutions • Poway, California, USA
    Full-time +1
    T2S Solutions company) is currently seeking to hire a.This role will be responsible for product compliance with internal and customer requirements spanning concept to addition the QE will develop ...Show more
    Last updated: 8 days ago • Promoted
    Quality System Engineer

    Quality System Engineer

    Sercomm • Rosarito, Baja California, Mexico
    Environmental, Health & Safety (EHS).This role offers a chance to work in a.Bachelor’s degree or above in Engineering or a related field. Excellent communication, coordination, and analytical skills...Show more
    Last updated: 30+ days ago • Promoted
    Supplier Quality Engineer PLANTA MEGA REGIÓN

    Supplier Quality Engineer PLANTA MEGA REGIÓN

    Thermometrics México, S.A. de C.V. • Tijuana, Baja California, Mexico
    Initiate, monitor or direct activities concerned with supplier quality, development and continuous improvement.Conduct thorough checks of quality systems and quality performance.Cooperation with su...Show more
    Last updated: 30+ days ago • Promoted