Qualityworks is a renowned brand in the field of medical device quality assurance and regulatory affairs. Led by Sharon Resnick, an experienced QA/RA expert with over 18 years of industry experience, Qualityworks specializes in establishing Quality Management Systems (QMS) and supporting companies from the concept stage to market entry.

As a Certified Manager of Quality and Organizational Excellence (CMQ/OE), Sharon has successfully guided numerous companies through regulatory submissions and ensured the production of safe and effective medical devices. With her deep knowledge of regulations and standards, she offers valuable insights and conducts internal and supplier audits to identify gaps and support remediation projects.

Qualityworks provides comprehensive services by acting as Quality Assurance and Regulatory Affairs Directors, leading QA/RA teams, and mentoring junior staff. The brand offers training, assists in designing and manufacturing medical devices, creates technical documents, and supports day-to-day activities and organizational objectives.

Collaboration is at the core of Qualityworks' values. The team believes in working together, doing the right work, and getting it done. They approach each project with dedication, aiming to deliver exceptional results and overcome obstacles by leveraging their practical experience and outside perspective.

With a love for their work, the team at Qualityworks constantly seeks improvement and stays at the forefront of industry developments to provide top-notch services. Sharon Resnick is highly recommended by her peers, partners, and customers, known for her professionalism, availability, and practical guidance.

Choose Qualityworks for reliable and effective quality assurance and regulatory affairs services in the medical device industry.