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Quality Manager

Ref: 577323

Greater Manchester / Lancashire / West Yorkshire

£55,000

  • Permanent
  • Regulatory Compliance
  • Quality Assurance
  • ISO, FDA And GMP Standards

About the candidate

The candidate is a highly skilled Quality Assurance Manager with a rich background in managing quality systems within ISO and FDA-regulated environments. 

Their expertise spans a variety of standards including ISO 9001, ISO 17025, ISO 13485, and ISO 27001. 

They bring a wealth of experience from working in the medical devices sector, focusing on regulatory compliance, equipment and method validation, and the implementation of Quality Management Systems (QMS) and Information Security Management Systems (ISMS).

Their career has involved significant roles at companies specializing in medical devices and healthcare products, where they have led teams in achieving and maintaining compliance with international standards and securing market certifications for new products in global markets.

What makes them great?

  • Navigating Global Regulatory Success: Spearheaded regulatory approvals for new medical devices, securing compliance with Australia’s TGA and Brazil’s ANVISA requirements, alongside CE Marking under EU MDR 745/2017 and FDA 510(k) submissions for Class I and IIa devices. This enabled market expansion, directly contributing to organizational growth and global reach.
  • Ensuring Compliance for Critical Devices: Has managed quality assurance and control testing for Class III and IIb medical devices, all under ISO 13485 and EU MDR standards. This candidate's precision in handling high-risk, implantable devices ensured patient safety and regulatory adherence.
  • Leading as a Certified Auditor with Dual Expertise: As an IRCA CQI Lead Auditor in ISO 27001:2022, this individual designed and maintained both Quality Management Systems (ISO 13485) and Information Security Management Systems for a surgical device business. By conducting internal audits, risk assessments, and delivering training programs, they ensured seamless external certifications. This rare combination of quality and cybersecurity expertise enables them to protect and enhance business operations in data-sensitive healthcare environments.
  • Driving Process Excellence and Team Growth: Across all roles to date, this individual has optimized Quality Management Systems through equipment and method validation (IQ/OQ per ISO 17025), SOP development, and impactful training initiatives, including creating a structured onboarding program that significantly boosted team productivity. Their proactive approach to continuous improvement and team elevation ensures they deliver measurable results while fostering a culture of compliance.

Areas of expertise

  • Quality Assurance and Regulatory Compliance: Expert in managing and auditing quality systems, ensuring compliance with ISO standards and FDA regulations, mostly within high-stakes environments such as medical device manufacturing. Extensive knowledge of
    • ISO 9001
    • ISO 13485
    • ISO 17025
    • ISO 27001
    • EU MDR
    • FDA
  • Audit Management, proficiency testing and risk assessment: Has led a number of detailed audits and is a qualified IRCA CQI Lead Auditor in ISO27001:2022
  • Project Management and Team Leadership: Proven track record in leading projects focused on regulatory approvals and quality system implementation, achieving successful outcomes in alignment with strategic business goals.
  • Training and Development: Skilled in designing and delivering training programs to enhance team capabilities and ensure widespread understanding of compliance and quality standards.