Orpha James serves as the Principal Consultant at Audits & QMS Inc., bringing over 25 years of extensive experience in the medical device industry, contract manufacturing, and quality engineering. Her expertise spans a wide array of critical areas, including design controls, validation and verification (V&V),...
Orpha James serves as the Principal Consultant at Audits & QMS Inc., bringing over 25 years of extensive experience in the medical device industry, contract manufacturing, and quality engineering. Her expertise spans a wide array of critical areas, including design controls, validation and verification (V&V), and regulatory compliance, particularly with the EU MDR/745 regulations and EUDAMED. Orpha is currently leading key projects focused on navigating the complexities of clinical evaluations and post-market surveillance, ensuring that clients meet stringent regulatory requirements across MDSAP countries, including the US, Canada, and Japan.
With a solid foundation in plastics formulation, Orpha has developed specialized thermoplastic elastomers and PVC for various applications, including medical parts and extrusion profiles. Her proficiency in auditing—encompassing first-party, second-party, and third-party audits—ensures that organizations maintain compliance with ISO 13485 and other relevant standards. Orpha's analytical approach to problem-solving is particularly evident in her work with sterilization processes, including Ebeam, Gamma, and ETO methods, where she applies her knowledge to enhance product safety and efficacy.
In addition to her technical skills in injection molding, extrusion, blow molding, and compression molding, Orpha excels in project management, CAPA, and risk assessment. Her ability to integrate quality management principles into manufacturing processes has made her an invaluable resource for clients seeking to optimize their operations while adhering to regulatory demands. Through her leadership at Audits & QMS Inc., Orpha James continues to drive innovation and excellence in the medical device sector, ensuring that products not only meet but exceed industry standards.
