Job Summary

Quality Specialist

  • Location:
    Santa Clara , California
  • Category:
    Quality Assurance
  • Contract Type:
    Contract/Temporary
  • Job reference:
    US_EN_3_105435_319168

Modis Engineering is seeking a Quality Specialist for our client in Santa Clara, that develops, manufactures and supplies a wide array of innovative medical diagnostic products.
The Quality Specialist will be a strong partner to the Global Quality and Regulatory function, as well as across the various Sequencing Solutions functions.
* Responsible for supporting development and implementation of Quality Management System (QMS) and supporting infrastructure/tools in compliance with FDA Quality System Regulation (QSR) regulations, International Standards Organization (ISO) regulations, and Roche corporate requirements.
*Actively participate in quality integration efforts for the Santa Clara site by supporting the planning, implementation and monitoring of integration milestones.
* Responsible for supporting project-related and QMS documentation using Electronic Document Management System (EDMS). Support coordination of document and record retention program for the site in alignment with the Roche corporate requirements.
* Support management and maintenance of training assignments for the site. Track, monitor and report site training compliance data. Partner with department managers and trainers to develop/ update training matrices.
* Write and revise Quality Systems procedures, perform gap assessments and assist in driving compliance. Understanding of laboratory procedures and GLP requirements is a plus.
* Experience in Change management, Supplier qualification, Inspection and CAPA management is an added advantage. Exposure to internal, external, laboratory, supplier auditing programs as appropriate.
* A proven ability to work creatively and analytically in a problem-solving and process-oriented environment. Expected to operate independently, holding him/herself accountable to proactively fulfill tasks and achieve results within assigned timelines.
* A proven ability to work in a collaborative, team-based environment dependent upon effective teamwork to achieve goals and company objectives.




* Bachelors’ degree in Biological Sciences, Engineering or related field, or equivalent combination of education and work experience.
* 2-4 years related experience in relevant medical diagnostic/device industry, including 1-2 years of direct Quality operations. Experience focused on quality systems, regulatory affairs/compliance or project management.
* ASQ Certified Quality Engineer (CQE), Auditor (CQA) and/or Six Sigma Green Belt a plus.
* Familiarity with relevant international ISO Standards (13485, 62304, 14971), and regulations (European medical/in-vitro devices directives, 21 CFR - part 820).
* Understanding of GMP and GLP requirements.
Competencies
* Enthusiasm for the role that Quality and Regulatory (Q&R) can play in enabling the development of new products for our patients.
* Be flexible with changing priorities/tasks and a desire for continuous improvement.
* Drive to engage positively with Q&R/Business teams and make impactful contributions in a multi-cultural/national environment.
* Strong interpersonal/communication/integrating/problem solving skills and demonstrated ability to collaborate effectively accross a variety of workgroups in demanding/changing situations.



If you are interested in this role, you can apply on our website at Modis.com, or you can send your updated resume in Word format to Julie.mcclung@modis.com

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All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Equal employment opportunity information:
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