John Love

The Oriel STAT A MATRIX consulting team averages 25+ years of life sciences industry experience and has deep expertise in US, European and global RA/QA requirements.

John’s Areas of Expertise

• Training – Managed all training activities for a manufacturer of mobile fluoroscopic imaging, ensuring all aspects of the training program were compliant to FDA regulations and ISO standards and all employees were trained in accordance to the latest regulatory requirements. Also developed and maintained records to demonstrate employee qualification and competence.
• Process and Production Controls – Led a manufacturing team in all aspects of their assigned functional areas, with accountability for the training, development, and performance management of team members. Regularly implemented actions to improve product and process quality as part of continuous improvement culture. Was involved in implementation of Unique Device Identification requirements to satisfy US FDA regulations.
• CAPA – As an internal investigator, managed 25+ inputs into the CAPA program from beginning to end, including evaluation of risk, investigation to root cause, CAPA implementation, and effectiveness check, as well as training other internal investigators.
• Auditing – Oversaw the development and implementation of internal auditor training and certification. Logged over 500 audit hours leading or participating in internal audits, covering 21 CFR Parts 11 and 820, ANVISA RDC, NMPA China, PMDA Japan, CMDR, ISO 13485:2003, and EU’s MDD. As an auditee, participated numerous times in audit readiness, inspection, and remediation activities associated with FDA QSIT, MDD, ISO 13485:2003 and 2016, CMDCAS, and ANVISA audits.

Highlighted Experience

• Oversaw all functional area production readiness activities associated with the release of 4 product families to market. Activities included process validation, training, segregation, movement, and integration of material, process documentation release, and area process flows.
• Implemented a redesigned flow of the back 1/3 of the production floor to meet production and material needs. As part of the implementation, achieved the following: 31% reduction of square footage, 47% reduction of WIP, and 31% improvement in lead time, all while maintaining or improving all quality metrics.
• Delivered 350+ hours of training for auditors to the EU MDR, ISO 13485:2016 and MDSAP, certifying over 150 auditors.