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A proposito di AbbVie

La missione di AbbVie intende scoprire e fornire medicine innovative per risolvere gravi problemi di salute attuali e gestire le sfide sanitarie di domani. Puntiamo ad avere un rilevante impatto sulla vita delle persone in diverse aree terapeutiche fondamentali: immunologia, oncologia, neuroscienze, oculistica, virologia, salute della donna e gastroenterologia, oltre a fornire prodotti e servizi al portafoglio Allergan Aesthetics. Per maggiori informazioni su AbbVie, visita l’indirizzo Seguici @abbvie su Twitter, Facebook, Instagram, YouTube e LinkedIn.

Quality Engineer

Irvine, California ID dell'offerta 2202107 Categoria Quality Assurance Divisione AbbVie
  • Champion Collaboration. Actively engage with data analysts, medical safety, manufacturing, and technical team members across the organization to ensure evaluation of product risk considers multiple inputs.
  •  Evaluate Risk. Aggregate and analyze data from multiple sources (e.g., complaints, manufacturing, medical safety, signal detection) and identify common trends.
  •  Present Assessment. Prepare presentations and reports to document the outputs of risk management monitoring activities.
  •  Escalate Risk. Use sound judgement to identify novel events, new risks, and changes to the risk profile; make recommendations to escalate or provide rationale regarding why escalation is not necessary.
  •  Update Risk Documents. Maintain Risk Management Files (RMFs) for commercial devices and combination products, including updates to Risk Management Plans/Reports, FMEAs, Hazard Analyses, User Risk Assessments, Design Risk Assessment, and Process Risk Assessments.
  •  Customer Focus. Proactively engage in championing best practices to drive a best-in-class Risk Management system. This could include actively reviewing clinical data, literature, and standards for state-of-art practices, then making recommendations to minimize product risk for patients.

Minimum Qualifications

  •  Degree in engineering, physical, or life sciences. Minimum education and experience requirements:  Bachelor’s degree: 3 years of experience o Master’s degree: 1 year of experience
  •  Technical knowledge in a scientific or engineering discipline
  •  Working knowledge of 21 CFR Part 820, ISO 13485, EU MDR, and ISO 14971
  •  Working knowledge of Design Controls and development of RMFs/FMEAs
  •  Experience supporting Quality Systems/Quality Assurance/Quality Engineering functions or related field (e.g., regulated GxP environment in qualification/validation, documentation, or compliance) in a regulated biotechnology industry: medical devices, and/or combination products, and/or drug products
  •  Ability to interpret scientific data, perform basic statistical analysis, and present the results to both technical and non-technical audience in a relevant format, including basic pivot tables and graphs
  •  The ability to recognize problems and take corrective measures
  •  Strong attention to detail 
  • Analytical, organized, with strong multitasking abilities
  •  Fluent in verbal and written English

    Preferred Qualifications
  •  Working knowledge of ISO/TR 24971, and/or ICH Q9
  •  Experience with device design and development and related risk files 
  • Experience with EN ISO 22242-1, IEC 62304, IEC 62366-1
  •  ASQ CQE or Risk Management certification
  •  Experience interacting with regulatory agencies
Significant Work Activities: Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: No
Job Type: Experienced
Schedule: Full-time

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