Mufeeda C.
Qa Ra Engineer @Kirkstall Precision
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WORK HISTORY
Qa Ra Engineer @Kirkstall Precision
Leeds, GB
Led and supported ISO 13485 & FDA-aligned audits, including internal, customer, and BSI audits, contributing to strong audit outcomes- Supported FDA audit activities, contributing to successful outcomes- Managed supplier quality across 270+ global suppliers, improving performance and eliminating supplier-related non-conformances- Executed IQ/OQ/PQ validation programmes for Class implantable device processes, including revalidation activities (e.g, passivation)- Led cross-functional projects for procurement, installation, and validation of manufacturing technologies, including laser marking and UDI systems- Managed core QMS activities and creating documents from scratch (CAPA, non-conformances, change control, document control, SOPs, risk assessment, FMEAs, gap analysis), including use of root cause tools (5 Whys, Ishikawa)- Supported EU MDR transition programmes and provided regulatory guidance across engineering and manufacturing teams- Conducted contract review activities, ensuring alignment with regulatory and customer requirements- Led projects to classify direct and indirect product contact materials, supporting customer biocompatibility assessments and regulatory compliance- Delivered training to cross-functional teams on regulatory requirements, documentation, and audit readiness- Supported process verification and product transfer activities for customers, ensuring compliance and successful execution
EDUCATION
Newcastle University
Master of Science - MS, Biomedical/Medical Engineering
Model Engineering College
Bachelor of Technology - BTech, Electronics and Biomedical Engineering
ABOUT MUFEEDA C.
I’m a Regulatory Affairs & Quality professional specialising in high-risk medical devices (Class with experience across EU MDR, FDA 510(k), and ISO 13485 environments. I have worked across the full product lifecycle, supporting and leading regulatory and quality activities for complex orthopaedic devices, ensuring efficient progression from development to market while maintaining the highest standards of safety and compliance. Key highlights of my experience include- Led and supported 12 EU MDR submissions (Class & IIb, large SKU portfolios)- Contributed to FDA 510(k) submissions - Delivered IQ/OQ/PQ validation programmes across manufacturing processes - Managed supplier quality across a global network of 260+ suppliers - Supported Notified Body and customer audits, contributing to strong audit outcomes I work closely with cross-functional teams across engineering, manufacturing, and quality to translate regulatory requirements into practical, audit-ready solutions. I’m open to new opportunities that combine regulatory strategy, innovation, and global market access, and I am available for roles in the UK and internationally, including Australia.
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