Quality Director Instrument
LumiraDx
Stirling, Glasgow, UK
3d ago

Role & Responsibilities

Quality Director - Instrument this is a multi-site role and will be required to travel across our sites in Stirling and Glasgow

The Opportunity

We are looking for someone who is able to manage a global team to support design and development for a complex innovative diagnostic testing device intended for point-of-care (POC) clinical settings covering the full lifecycle of the product whilst ensuring that quality and timeline goals are met.

You will enthusiastic, able to deliver on their challenging goals and able to set clear and consistent direction to ensure your team delivers.

You will lead the Global Multi-site planning of development quality activities related to compliant on time introduction of all instrument, including software and any ancillary items through design and development and change management on market.

Provide strategic and technical guidance to LumiraDx in the core team / NPI model and develop the team in Instrument quality and global regulatory compliance.

Key Roles and Responsibilities

  • Leadership of the Instrument development quality process though lifecycle.
  • Ensuring that technical issues are not encountered or where encountered, overcome quickly and robustly.
  • Ensure successful quality transfer of Instrument designs into validated manufacturing, carrying out necessary risk assessments, design verification and validation activities are undertaken and fully documented and traceable.
  • Oversee Design History File updates based on new product and any changes.
  • Establish process for ensuring Test method validation is carried out for all Instrument In process and QC release meet acceptable quality standards and ensure kept up to date based on field information and changing post market surveillance.
  • Lead the quality process for traceability and quality records maintained throughout Lifecyle.
  • Ability to understand complex instrument technology including optical, heating, piezo-electric, magnetic, electronics & software including communication subsystems and ancillary items
  • Director level leadership, strategic thinker that can act tactically whenever needed.
  • Ability to manage multiple quality disciplines in instrumentation quality including teams in Hardware, software, system integration and prioritisation of the teams activities.
  • About You :

    We are looking for a highly motivated leader with exceptional attention to detail and high level of skills in problem solving and strategic thinking, along with the following experience :

    Essential skills

  • Extensive experience of complex instrument design and development and manufacture quality processes
  • Director level leadership, strategic thinker that can act tactically whenever needed.
  • A degree in Quality Engineering / Engineering or similar relevant qualifications.
  • Computer literate with a good knowledge of MS Office products
  • Communicate effectively with stakeholders.
  • Ability to correctly identify & resolve instrument quality issues with the use of any tools necessary. Including statistical and other Lean Six sigma tools.
  • Relevant technical experience in the medical device (or similarly regulated) industry.
  • Expert level project management skills.
  • High level of ability to manage many multiples of key suppliers in dynamic situations.
  • Desirable skills

  • Experience in a high volume manufacturing environment.
  • Six Sigma Green Belt or Black Belt Qualification.
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