Head of Quality, Med-Tech / Healthcare
This is an exceptional opportunity for a high-energy Quality Professional to step into a leadership role and have a significant impact on the company. The Head of Quality is a newly established role in the company and will be responsible for leading high-performing quality and compliance teams. The successful candidate will be a change-leader tasked with building a quality culture across the organization and strike a balance between implementing the processes and structure required to protect the organization's assets while ensuring the business remains flexible and positioned for growth.
Provide clear and concise vision for the quality and compliance
Develop cross-company buy-in and ensure all teams exhibit a quality mindset.
Facilitate interdepartmental communication to improve responsiveness and facilitate prompt decision-making.
Attract, engage, and develop a high-performing quality team.
Build team capacity through coaching and thoughtful career planning.
Quality and Compliance Strategies
Provide leadership in the development and successful execution of the company’s quality management and compliance strategies, policies and plans.
Advise the CEO on all compliance and quality related aspects of the company.
Build high-trust collaborative relationships with the executive team to ensure strategic alignment of the quality and regulatory functions for the company.
Quality and Compliance Management
Oversee effective day-to-day operations for the quality and compliance functions of the company.
Establish a Total Quality Management system and drive it through the organization.
Oversee the internal audit program and ensure compliance with all applicable regulations for medical device development and manufacturing operations.
Guide internal teams to assure that all operational and development activities conform to business and regulatory requirements.
Establishing and maintain relationships with key professionals and regulatory bodies.
A bachelor’s degree in a scientific discipline
5-8 years’ experience in a quality leadership role
Expert knowledge of regulatory strategy creation, design control, cGMP/Quality Systems and ideally with experience in FDA, EU, and ISO regulations and standards.
Exceptional communications skills with the ability to gain buy-in with C-level executives as well as team members.
High-energy, creative and with a collaborative working style
For more information, please contact
Tim Swanson email@example.com