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Employment Type:
Full time
Job Category:
Manager, Mfg/Ops Quality
(This job is no longer available)
Illumina, Inc. | San Diego, CA
Grad Date

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Job Description

Job Description

Position Summary:
This position is a leadership role within the organization and is accountable for driving change, establishing sustainable business processes, improving products, and providing management with actionable business and product data.   It is accountable for providing Quality oversight and support aligned with the San Diego operations team.  This position will serve as a leadership resource to manufacturing and quality engineering to improve product quality, reliability, and process capability. The position requires exceptional communication, interpersonal skills, and project management skills to effectively coordinate activities and deliver results. This position reports to the Head of Quality, San Diego.


  • Identifies resource needs and facilitates procurement of resources, resolution of resource conflicts, and business justifications and/or trade-offs related to resource utilization;
  • Builds effective, cross-functional teams that accomplish sustaining supporting and project objectives on a prescribed schedule and with a prescribed budget;
  • Grows talent within the organization by leading employee development initiatives.
  • Participates in the definition of area goals and drives teams to deliver on goals;
  • Leads organizational management of a team of dedicated Quality Specialists and Quality Engineers that may elements of include consumable product manufacturing, testing, release and distribution activities.
  • Drives continuous improvement initiatives to advance quality processes and capabilities;
  • Advocates strategically and operationally effective solutions to complex problems;
  • Contributes quality and compliance expertise and guidance to teams responsible for addressing specific quality issues;
  • Establishes and monitors process metrics and develop action plans as needed;
  • Works with business process owners to identify and implement solutions to track and action quality KPIs
  • Reviews non-conformance and CAPA reports. Tracks program health for the San Diego site.
  • Leads or provides subject matter expertise during internal and external quality system audits;
  • Leads or represents functional area in Management Review and Quality Review processes;
  • Leads or represents functional area in material review board and CAPA review board.
  • Provides management with plans and status updates on assigned responsibilities and goals and escalates issues in a timely fashion;
  • Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices; Establishes and supports best practices for problem solving, root cause analysis, and solution selection tools;
  • May act as a delegate for the Quality Assurance site lead.

All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.

  • 7-10 years of experience in quality assurance in a regulated environment (FDA, EMA, ISO13485); direct experience working in in-vitro diagnostic manufacturing preferred;
  • Experience in implementing and leveraging metrics;
  • Adaptable to fast-paced, dynamic work environment and shifting demands;
  • Ability to work in a matrix organization;
  • Extremely strong communication, interpersonal skills and customer focus;
  • Strong leadership skills with demonstrated ability to effectively work across teams and functions;
  • 5-7 years of experience in managing people/resources effectively to accomplish established goals;
  • Proven capacity to effectively manage and escalate risk;
  • Demonstrated success in a position requiring highly effective communication, facilitation and negotiation skills;
  • Must be open minded, collaborative and able to work in a non-hierarchical environment;
  • Must be able to look at processes high level as well as zoom in on a detailed level;
  • Project management skills preferred.


  • Bachelor’s degree in an engineering or scientific discipline;
  • Graduate degree in an engineering or scientific discipline and/or business strongly preferred;
  • Quality and/or Regulatory Affairs certification desirable (e.g. CQM, CQE, CQA, RAC);


Illumina believes that everyone has the ability to make an impact, and 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. If you have a disability or special need that requires accommodation, please contact us at applications@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

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About Illumina, Inc.

Illumina, Inc. is a developer, manufacturer and marketer of integrated systems for the large-scale analysis of genetic variation and biological function. The Company provides a comprehensive line of products and services that serve the sequencing, genotyping and gene expression markets. It also, develops and commercializes sequencing technologies used to perform a range of analyses, including whole genome re-sequencing, gene expression analysis and small ribonucleic acid (RNA) analysis. Its customers include genomic research centers, pharmaceutical companies, academic institutions, clinical research organizations and biotechnology companies. The Company operates in two business segments: Life Sciences and Diagnostics. On August 1, 2008, the Company acquired Avantome, Inc. The Company’s subsidiary is Solexa, Inc. (Source: 10-K)