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Over AbbVie

De missie van AbbVie is het ontdekken en leveren van innovatieve geneesmiddelen die vandaag een oplossing bieden voor ernstige gezondheidsproblemen en de medische uitdagingen van morgen aanpakken. We streven ernaar om een grote impact te hebben op het leven van mensen in verschillende belangrijke therapeutische domeinen: immunologie, oncologie, neurowetenschappen, oogzorg, virologie, vrouwengezondheid en gastro-enterologie, naast producten en diensten uit de portefeuille van Allergan Aesthetics. Bezoek www.abbvie.com voor meer informatie over AbbVie. Volg @abbvie op Twitter, Facebook, Instagram, YouTube en LinkedIn.

Quality Engineer

Irvine, Californië Job ID 2202107 Categorie Quality Assurance Afdeling 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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