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, marketing and website design. Her career, focused on the small to mid-sized medical device manufacturing sector, provides a variety of experience and skills. Areas of experience include quality assurance, product branding, global marketing, and international sales. She has a comprehensive background in managing products from development to maturity, generating marketing materials, including print, presentation, video and website design.
She specializes in ISO 13485, ISO 9001 and FDA 21 CFR Part 820 regulatory requirements and is a certified Quality Management Systems Lead Auditor for ISO 13485 and ISO 9001 through Exemplar Global. Her experience includes creating and implementing a quality management system that successfully passed multiple FDA audits and achieved ISO 13485 and ISO 9001 certification. As a highly organized and detail focused professional, she excels at quality audits, company process evaluation, and document preparation.
She 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.
“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 marketing and quality departments. 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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