UK Head of Quality

2 weeks ago

Cambridge, United Kingdom RRxCo.™ Full time

RRxCo is partnered with a leading Life Science Manufacturer in the search for a UK Head of Quality to support significant growth. They are seeking an experienced leader to drive standards as a top-tier Life Sciences manufacturer. You will lead Quality advances across their team of 400 colleagues, build a dedicated Quality team in the United Kingdom (UK), and grow a culture of world-class quality.


Deliverables

  • Develop, implement and manage the Quality system and strategy, to ensure it meets the business requirements and customer deliverables.
  • Lead, manage, and recruit an effective Quality team ensuring compliant and effective training and development.
  • Champion and work with the wider business to deliver and sustain ISO9001:2015.
  • Build and refine a fit-for-purpose supplier assurance model whilst implementing effective risk management processes and tools.
  • Introduce and mould a best-in-class Quality culture whilst maintaining and improving the effectiveness of the business.
  • Support and lead as the Quality SME for internal business projects such as the building of a metrology laboratory.
  • Ensure the business maintains and improves regulatory readiness through organic growth and future acquisitions.
  • Be accountable and provide SME Quality advice whilst the business transitions into ISO13485 accreditation.
  • Build and maintain strong relationships with the rest of the SLT and key stakeholders.
  • Continuous improvement and updating of the Quality Management System Framework and Strategies to ensure compliance with current regulatory requirements and alignment with the broader business plan.


Profile of Individual

  • Degree (preferably Masters/PhD) or equivalent in Engineering, Chemistry/Life Sciences, or a related scientific/technical field.
  • Extensive years of relevant experience in Life Science/Medical Devices with experience in a supervisory/management role with demonstratable progression in managerial responsibilities.
  • Ideally knowledge/experience of complex products within instrumentation including software components/elements.
  • Expertise and proven working experience with current ISO9001:2015 and ISO13485 standards.
  • Ability to collaborate and influence across multi-functional teams and stakeholders.
  • Excellent verbal and written communication skills, and experience with technical writing including authoring and revising SOPs and technical reports.
  • Familiar with working in a fast-paced complex environment, able to work flexible schedules.
  • Ideally, past or current experience working within a Life Science organisation (primarily a Medical Device organisation).
  • Lead Auditor certification would be beneficial.
  • Six Sigma (minimum Green Belt) would be advantageous to support the continuous improvement journey.

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