Kimberly Kelly

Rewrote the QMS (40+ procedures), revamped equipment and process validation systems, and implemented a Supplier Quality program that prevented 10 ISO 13485 audit findings; hired and developed the site quality team.

Authored and approved IVD manufacturing documents (batch records, CAPA, CC, MRB), supported FDA PAI and notified body audits, and re-validated processes producing FDA-approved supplemental validation reports.

Led EU-MDR remediation for manufacturing and validation teams, authored and executed TM/TMV and IQ/OQ/PQ protocols, managed direct reports, and improved validation acceptance and deviation handling.

Performed EU-MDR gap analysis and remediation, led test method validations, oversaw R&D technicians and supported $8.8M in operational synergy savings through quality initiatives.

Authored supplier management and training processes, executed validation protocols for new products, and performed cleanroom environmental testing while acting as interim Quality Manager when needed.

Assessed medical device QMS to ISO 13485 and CE marking, managed follow-up on audit findings and CAPA approvals, and conducted client-facing audits with full travel responsibility.

Supported medical device product development (DFM, PFMEA), led fixture/equipment design and FAT/SAT, authored SOPs, validations and DHF documents, and executed IQ/OQ/PQ and capability studies.

Managed quoting, budgeting, scheduling and communication for plastic injection molding projects, prioritized cleanroom production and maintained project timelines using Microsoft Project.

Bachelor of Science in Mechanical Engineering from the University of Iowa as listed in training and knowledge section.