Nathan Obrien
Senior Quality Assurance Manager (Contract Manufacturing) @Smith Nephew
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WORK HISTORY
Senior Quality Assurance Manager (Contract Manufacturing) @Smith Nephew
Kingston upon Hull, GB
Responsible for developing and maintaining the Quality Engineering, Quality Release and Complaint Investigation teams for the Purchased Finished Goods (3rd Party Manufacturing) business units of Advanced Wound Management. Working in close collaboration with the PFG functional leads to maintain day to day business requirements, product sustainability and strategic programs for continuous improvement and growth- Establish and maintain key performance indicators and metrics, including lead and lag measures - Maintain adherence to key quality procedures, such as CAPA/Deviations/Release Process/Complaint Investigation - Promote and foster a working culture built on continuous improvement and cost saving initiatives, employing methodologies such as Lean Six Sigma, DMAIC and ensuring the implementation of data driven decisions - Work with cross-functional operations, supply chain and quality stakeholders to develop an end-to-end supply chain improvement roadmap, including key elements of supplier risk management, supplier audits, supplier development- Team development and progression planning - Performance management - The management of significant elements of the site quality system. Presents Quality Management processes to External Auditors including Notified Bodies - Ensure compliance to relevant GMP/GDP and Quality Systems standards, specifically FDA Regulations, MDD, MDR and ISO 13485
EDUCATION
The University of Hull
Bachelor of Science (BSc) (Hons)
The University of Hull
Master of Science (MSc)
Wyke 6th Form
A Levels
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