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Head of Quality

2 months ago

Cambridge Cambridgeshire, United Kingdom RRxCo.™ Full time

Job Description RRxCo is partnered with a leading Life Science Manufacturer in the search for a UK Head of Quality to support significant growth. 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.

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.
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.
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.

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.
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).

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