Michelle Kisiel

WORK HISTORY

EDUCATION

ABOUT MICHELLE KISIEL

I am a detail-oriented individual, who strives to establish clear, specific goals in my work and to produce measurable results. My understanding of operational processes and audit methods makes me a capable, practical problem-solver, trouble-shooter, and innovator. I am passionate about ensuring my work is fully compliant with regulatory processes, and take great pride in the safety of the devices I work on. As a subject matter expert in the medical device industry, my strong background in design controls helps me to not only audit the process, but also audit the effectiveness of the process. I have had the privilege of being a key contributor to successful internal and external audits, including FDA 21 CFR Parts 11, 58 & 820, ISO 13485, CMDR, CFDA, JPAL MO 169, MDSAP, ANVISA RDC16, TGA 2002, EU MDD, & EU MDR.KEY COMPETENCIES:• Analyzing and applying regulatory requirements to processes and products to ensure compliance.• Collaborating with Regulatory Affairs for device registrations, including 510k submissions and recertification efforts with notified bodies.• Influencing cross-functional teams to ensure full compliance with internal QMS procedures. • Effectively communicating across all functions of leadership to manage concurrent projects.• Developing test plans, test scenarios, test cases, test reports, trace matrices, and test metrics.• Preparing biocompatibility assessments and strategies per ISO 10993 and ISO 18562.• Conducting risk management activities in accordance with ISO 14971.• Designing cleaning and disinfection test protocols to meet industry reprocessing guidelines.