Director of Quality, Tissue Director

• Aug 2021 - Present

ISO Management Systems Consultant

• Jul 2015 - Present

I lead quality system consulting and audit engagements for medical device, pharmaceutical, and biologic companies. Some of the services I offer include: • Designing, implementing, GAP Analysis, and documenting Quality Management Systems. • Providing fractional Director of Quality services for selected companies. • Conducting U.S. and international quality system reviews and audits using ISO 13485, 21 CFR 820, CFR 210 & 211, AATB, and cGMP, CFR 806, CFR 803, MDSAP. • Managing FDA inspections, ISO certifications, and 483/warning letter remediation and responses. • Developing and delivering quality and compliance training programs for company staff. Show less

Independent Contractor Medical Device

• Aug 2018 - Aug 2021

Lead Auditor performing 3rd Party Audits to ISO 13485:2016 and ISO 9001:2015 Lead Auditor performing 3rd Party Audits to ISO 13485:2016 and ISO 9001:2015

Compliance Auditor - Corporate Compliance

• Mar 2013 - Jul 2015

I performed quality audits on internal company systems, including operations and manufacturing, suppliers, and recovery partners (tissue recovery organizations). I managed multiple types of 3rd party audits, including Customer ISO 13485, FDA, AATB, state agency, international regulators, and Notified Body audits. I also assisted with the design and implementation of QMS policy and procedures and the company’s CAPA program. I provided training to new operational staff and quality employees. In this role, I: • Contributed to the success of the company’s QMS/compliance programs by conducting and supporting approximately 60 quality (manufacturing & laboratory), AATB, and FDA audits annually at U.S. and international facilities. • Assisted in the resolution of an FDA warning letter by creating and delivering remedial quality/compliance training for the entire company. • Improved quality compliance by redesigning the employee quality training program. Show less

Director of Client Services

• Jan 2012 - Mar 2013

I provided quality and project management consulting to medical device clients. I designed and implemented QMS and supplier quality audit programs in compliance with applicable FDA regulations and ISO standards. I also conducted quality reviews and audits of clients’ internal operations and supplier base. I developed and delivered quality training to client and supplier staff. Highlights include: • Facilitated a medical device launch by assisting with an FDA 510k submission and providing project management support for a start-up company. • Reduced a client’s compliance risk by redesigning its QMS and spearheading continuous improvement initiatives. Show less