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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.

 Responsibilities:

Quality Leadership 

  • 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.

Requirements:

  • 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 tim@corporate.bc.ca