Job Description

Position Summary

The Medical Device Combination
Product Specialist is to provide quality oversight and support for clinical and
commercial combination products from introduction throughout the product and
design control lifecycle and the associated Quality System. 

The Medical Device Combination Product Specialist is
a member of the Global Quality Organisation who is a quality liaison between
Global Product Development (US Based), Manufacturing Operations, Quality
Control, and Quality Assurance (US and Ireland) to ensure regulatory compliance
with design control activities and documentation, technology transfer to
manufacturing and QC testing processes. The role enables efficient
communication and decision making related to the quality and design control of
our combination products.

The position reports into the Quality Medical
Device Combination Product Lead and is a member of the Medical Device Quality
Team (MDQ).

Responsibilities:
  •  Responsible for maintaining device
    CMO Quality Assurance

  •  Liaise with CMO for device
    complaints, investigations and root cause assessments.

  •  Support documenting and periodic review of supplier
    quality requirements and supplier quality agreements.

  •  Support the development of the
    design control quality plan in line with applicable regulations for combination
    products  including Planning, Design and Development, Verification, Validation, Technology
    Transfer and Risk Management.

  • Provide Quality oversight for the
    development, review, and approval of key Design History File deliverables
    including Verification and Validation Protocols and Reports, Risk Management
    deliverables, Transfer Plans, Design Reviews, Design History File management and supporting operational procedures. 

  • Facilitates global and local
    changes with respect to the product and design control

  • Ensure timely entry, processing,
    and closure of quality records in compliance with Alexion’s procedures.

  • Support risk assessments relating
    to product quality for clinical and commercial products.

  • Supports Notified Body and Health
    Authority inspections and compliance.

  • Ability to work cross
    functionally with Development, Tech Ops, Quality Assurance.

  • Communicate effectively, both
    verbally and in writing, internally across departments and with external
    partners.

  • Comply with the Alexion’s quality
    assurance requirements as well as applicable regulatory requirements.

  • Other duties as assigned.


Requirements

Education and Key Competencies: 

  • Minimum
    of a B.Sc. degree in biological / chemical sciencies, biomedical / mechanical engineering, or other related subject.  

  • Minimum
    of 4+ years’ experience in Quality with medical device or combination products
    in a regulated environment.

  • Risk Management
    Standard for Medical Devices ISO 14971 2019
  • Knowledge of the regulatory and compliance
    requirements of design control for medical devices and/or combination products
    (e.g. FDA QSR 21 CFR Part 4 and 820 / ISO 13485 and Regulation (EU) 2017/745).
  • Familiarity
    with SAP and Trackwise would be desirable.
  • Excellent
    communication & presentation skills.
  • An
    ability to work independently, as well as a member of a team in a dynamic, fast
    – paced environment.

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