QMS Specialist - Medical Devices

Our client, a Global Medical Device Manufacture has an immediate opening for a QMS Specialist for a 12 Month + Contract.   Our client offers results-driven people a place where they can make a difference - every day!  You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment. 

Thorough knowledge and understanding of US and International Medical Device Regulations, including MDSAP, with direct experience in US 510(k) and EU Class II devices.

Position Description (Principle Duties and Responsibilities)

• Developing and implementing policies and procedures to ensure compliance with medical device regulations across multiple markets.
• Conducting thorough internal audits to verify adherence to quality standards and preparing for external regulatory inspections.
• Analyzing audit findings and data trends to identify areas for process improvement and risk mitigation.
• Collaborating with cross-functional teams to design and refine processes that meet regulatory and quality management requirements.
• Reviewing design documents, manufacturing and testing data to ensure consistent compliance throughout product development.
• Facilitating training sessions to educate staff on quality protocols and regulatory updates.
• Coordinating with regulatory bodies to gather feedback and implement corrective actions based on audit outcomes.
• Managing documentation systems to accurately record quality activities, non-conformances, and corrective actions.

What you need

• Extensive knowledge of US and international medical device regulations, including MDSAP, with practical experience in US 510(k) submissions and EU Class II devices
• Strong understanding of Quality Systems, including measurement, analysis, improvement, adverse event reporting, design and development, and production controls
• Significant audit experience and familiarity with regulatory standards such as ISO 13485 and ISO 9001
• Exceptional communication, project management, and influencing abilities
• Ability to manage multiple tasks effectively in a fast-paced environment
• Strong interpersonal, written, and oral communication skills
• Analytical mindset with excellent problem-solving capabilities
• Experience working in cross-functional teams and making sound, timely decisions
• Customer-focused approach with a knack for technical writing and procedure development
• Proficiency in computer tools and systems; some travel may be required