Orpha James – Consultant, Quality Systems/Regulatory Affairs

Orpha is a highly accomplished Lead Medical Auditor and Consultant with an outstanding history of comprehensive management and engineering experience in Research & Development, Manufacturing, Quality Control, and Project Management in the medical device arena.

Orpha has successfully audited more than 483 companies across 11 countries, in her more than 15 years of experience as Medical Devices Auditor. She has been Lead Medical Device Auditor for TÜV Rheinland and InterTek & NSAI USA, covering different standards and areas of expertise such as Medical Product Assessment, QMS, ISO 13485:2016, ISO 9001, ISO 14971:2019, ISO 17021:2015, MDSAP Certificate, CMDCAS Certificate, MDD Certificate, MDR Certificate, Design Controls, Process Controls, Plastics Materials, Biotechnology, Biocompatibility, Nano Materials, and Dental Implants. She is also an expert in the Sterilization Standards ISO 11137:2018, ISO 11135: 2015, and ISO 17665:2017.

Orpha has over 20 years in her distinguished career, with roles of increasing complexity and responsibility with Aaron Industries, Boston Scientific, Nypro Healthcare, Medtronic, and Zoll Medical. She has been recognized for achievements in developing systems, processes and procedures to streamline operations, increasing revenues, and enhancing profit performance. Among Orpha’s strengths are her in-depth experience developing high-level product requirement definition documents, customer requirement specifications, and product performance specifications, as well as her proven ability to anticipate and troubleshoot problems, strategize resolutions, and consistently implement effective solutions by thinking strategically with strong capacity to identify opportunities and develop solutions while using insight to challenge, adapt, and improve current approaches/ways of doing things.

Orpha holds a B.Ed. Teaching Science and B.Sc. Chemistry & Biology degrees, as well as two Master of Science Degrees, in Biotechnology (Worcester State University) and Plastics (University of Massachusetts Lowell, College of Engineering). She is also a Board Member of the Pioneer Valley Society of Plastics Engineers (SPE), and a member of the American Society for Quality (ASQ). Orpha is active volunteering her time, knowledge, and experience at Bacti-Lab Malden Hospital, Ruth Harvest Pantry, and at the Education Division of the Northborough Juniors Women’s Club.

Always Keep Improving!