1+ months

Staff IVDR Compliance Specialist

Illumina, Inc.
San Diego, CA 92101
  • Job Code
    20036-JOB

Responsibilities:

Global QMS Scalability:

  • Refine end-to-end business processes to integrate IVDR into QMS requirements (from gap assessment to detailed project plans)
  • Identify interlinkages & cross-site dependencies in business processes; ensure identified linkages, dependencies and risks are seamlessly managed in detailed project plans
  • Define requirements for a State of the Art cGMP environment: Incorporate external references / requirements--i.e., IVDR Implementing & Delegating acts, Harmonized Standards, and guidance from Competent Authorities & Notified Bodies
  • Create, edit, and maintain QMS documentation, including but not limited to, global/ departmental policies, procedures, work instructions, forms, templates, and training materials
  • Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
  • Advises and consults on QMS project/quality plans, risk assessments, remediation plans and change management plans.
  • Drive closure of IVDR QMS related CAPA

Enterprise Systems (Requirements Development e.g. PLM)

  • Define & help transfer Business Quality Requirements for IVDR into system requirements (from solution building to integration) to bridge GIS & Business Process Owner/functional requirements (e.g. PLM, IVDR)
  • Ensure consistency in business requirements across systems/solutions & integrate with Quality requirements
  • Help with documentation and execution of user acceptance tests (UAT)

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.

Requirements:

Global QMS:

  • Proven experience in meeting and applying medical device regulations and standards across QMS processes (21CFR 820, ISO 13485, ISO 14971, MDSAP Country Requirements, MDD/MDR, IVDD/IVDR)
  • Technical knowledge and experience in providing QMS compliance oversight and attaining/maintaining regulatory certification
  • Demonstrates strategic agility and can implement opportunities to optimize global processes and develop best practice
  • Possess negotiation, interpersonal, and partnering skills; demonstrates leadership skills, works well within teams, and is effective in influencing stakeholders (global & local/site-levels)
  • Ability to effectively prioritize & re-prioritize based on risk & criticality; flexible, with ability to work effectively and independently in a fast-paced, dynamic environment with shifting and competing demands and high level of ambiguity/uncertainty
  • Strong communication (verbal, written) and presentation skills: can communicate in a timely, thorough, and concise manner.
  • Intermediate to advanced experience with presentation, data analysis, and visualization tools (e.g. MS Excel, Visio, PowerPoint)
  • Quality Certification preferred (e.g., CQE, CQA, SQE, 6-Sigma, or similar certifications)

Enterprise Systems (Requirements Development e.g. PLM)

  • Business and systems analysis experience in requirements gathering, writing software requirements, process modeling, and data mapping.
  • Strong experience in business process management, problem definition, design, solutions evaluation, validation and deployment. Enterprise level IT systems experience preferred.
  • Demonstrated ability to communicate across all levels of the organization; ability to clearly articulate complex technical ideas to a non-technical audience both verbally and in writing
  • Strong background with relevant PLM/ Manufacturing/ CRM systems; prior experience in health/medical device industry is highly preferred

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

Experience/Education:

  • Typically requires a minimum of 8-10 years of related experience with a Bachelors or Master's degree; or equivalent experience
  • 8+ years of experience in quality assurance (or related experience) in a regulated environment; direct experience working in in-vitro diagnostic manufacturing preferred

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 require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf





Posted: 2020-04-25 Expires: 2020-05-27
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Staff IVDR Compliance Specialist

Illumina, Inc.
San Diego, CA 92101

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