This candidate is a senior QARA professional with a strong foundation in engineering and a passion for advancing accessible medical technology. With experience spanning medical devices and in vitro diagnostics, they bring a deep understanding of global regulatory frameworks, quality systems, and product lifecycle documentation. Their background includes leading QA activities from concept through commercialisation, managing design transfer, risk documentation, and regulatory submissions across multiple jurisdictions.

They are known for driving continuous improvement initiatives, resolving complex CAPAs, and fostering cross-functional collaboration to ensure compliance and efficiency. Their technical toolkit includes statistical analysis, fault-finding, and documentation review, supported by hands-on experience with lab equipment and basic programming. With a track record of hosting audits, mentoring teams, and contributing to strategic quality planning, this candidate combines analytical rigour with a proactive, mission-driven mindset—making them a valuable asset to organisations committed to ethical innovation in healthcare.

If you’re interested in exploring how someone like this could contribute to your organisation, please contact Andrew Welsh at Newton Colmore on 0121 268 2240 or andrew.welsh@newtoncolmore.com

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