Stryker orthopedic

I held a key role in managing the packaging sub-department for the MAKO rehabilitation project and served as the point of contact for the design dossiers in compliance with EU-MDR. My responsibilities extended to supporting qualification and validation tasks related to packaging remediation, following GMP, FDA, and ISO standards. I was part of a usability research study examining nurses' response times to opening orthopedic implant packaging in sterile environments, overseeing protocols, and documenting over 30 usability studies. My role also entailed regular interaction with vendors for sample collection, documenting previously conducted tests, and communicating project updates. Further, I was proficiently trained in packaging validation tests, aligning with ISO11607, ISO13485, and ISO11737 standards.