Chanda Owens

Background

About Chanda Owens

I am energized when my quality & compliance strategies add value to an organization and make a strong impact. I am passionate about facilitating the progress of launching new products into foreign markets and expanding the organization’s impact across the globe. I am delighted by the moments that take place when the quality and compliance strategies that I create with my team reach key milestones. I am efficient in overcoming hurdles that allow the business to push forward. I accept the challenge to transform teams through mentoring, coaching, and bringing quality & compliance goals to life. I have learned the art of facing the unknown with adaptability, integrity, creativity, and collaboration. Throughout my time as a leader, I have acquired expertise that I use to help senior leaders through risk mitigation efforts. I enjoy cultivating strategies with an open and strategic mindset. Examples of my recent career highlights include: • Enhanced quality and compliance processes across 43 countries after divesture. • Established the first global management system (during height of the pandemic) by traveling to different countries and implementing a plan to meet each government’s quality standards. • Cleared a 7-year-old warning letter by creating and implementing a corrective action plan. • Improved compliance in the first 6 months by restructuring the design control processes, revamping change control processes, and standardizing sterilization procedures. • Accomplished shifting culture to being more quality-driven by collaborating with leaders and workers to address barriers in achieving quality goals and initiatives. • Awarded Innovator of the Year for completely redesigning quality and compliance. • Skyrocketed employee engagement scores from 60% to 98% and decreased employee turnover from 30% to 3%. I have demonstrated deep expertise in medical device and diagnostics regulations and standards such as: ISO 13485, FDA QSR 21 CFR part 820, 806, 803, EU MDR, IVDR, MDSAP. I have provided my knowledge and guidance to leaders in business throughout many different cycles, and I’ve cultivated a solid reputation for strengthening collaboration and adding value. I enjoy providing guidance that helps the executive team not only become aware of risks but also provides valuable insight that is key to keeping business moving forward. Certifications: Six Sigma Black Belt Certified, ASQ Certified Quality Auditor