Christina Scalise is the founder/owner of CLS Consulting Services, LLC. She is a quality and product management executive with extensive experience in quality management systems, product management, and medical device manufacturing. Her career, focused on the small to mid-sized medical device manufacturing sector, provides a variety of experience and skills. Areas of expertise include quality management system auditing, quality assurance, design and development, and product management. She has a comprehensive background in 3rd party, supplier and internal auditing (including remote auditing techniques), quality system management and bringing products from concept to market.
Christina specializes in ISO 13485, ISO 9001, FDA 21 CFR Part 820, MDSAP, EU MDR and EU IVDR requirements. She has been a certified Quality Management Systems Lead Auditor for ISO 13485 and ISO 9001 through Exemplar Global. Her experience includes 600+ days of auditing and implementation of a successfully certified quality management system. As a highly organized and detail focused professional, she excels at quality audits, company process evaluation, and document preparation. Christina has a demonstrated ability to problem-solve, learn and apply new skills/technology, and effectively organize and lead cross-functional teams. Excellent interpersonal communication, a goal-oriented approach, and effective prioritization skills allow her to accomplish objectives within timelines and budget. |
ISO 9001 Lead Auditor
ISO 13485 Lead Auditor
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“Both personally and professionally, I am passionate, organized, and motivated. I pride myself on a high level of service. My parents were small business owners and my work experience has focused on the needs of businesses that may not have the budget to support full-time quality resources. This gives me an advantage to working with clients that want to get the most for their money. When they choose me, they can expect the highest level of service and communication.”
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