Job Description

Basic Function:

• Directs the effective development, implementation and continuous improvement of the organization’s quality assurance policies and procedures.
• Assures that the Quality Management System are in compliance with medical device standards (ISO13485) and global regulations.

Principal Responsibilities:

• Align and update the Quality Management System according to official standards and regulations as well as internal requirements.
• Promotes effectiveness and efficiency in the development of the Quality Management system.
• Ensures effective implementation of the Quality Management System.
• Is the product quality champion within the organization, ensuring safe high quality products for end users and customers.
• Main responsible hosting health authorities inspections and external audits
• Be an organization’s quality & regulatory expert and customer advocate
• Ensure a globally aligned Quality Management System
• Ensures the implementation and understanding of the Quality Policy
• Report on the Kelvi Quality Management System objectives (performance)
• Lead problem solving efforts.
• Expand the use of data collection, analysis, and data presentation throughout the organization.
• Guide and encourage others to “Speak with Data” and utilize root cause problem solving

Qualifications:

• Proven ability to create the Quality and regulatory strategies for an organization and experience lead others to achieve the related goals.
• Bachelors degree; at least 5 years of related experience and/or training; or equivalent combination of education and experience. Experience in some combination of Regulatory and Quality roles, some portion of which must include a manufacturing environment and medical devices, with a strong focus on quality assurance and regulatory responsibilities.
• Extensive knowledge of Medical Device standards (ISO13485) and regulations (FDA, Health Canada, European Regulations)
• Medical Device Experience
• Leadership and supervisory experience
• The ability to influence quality and regulatory both within and outside the organization with a strong focus on the customer
• Communication skills - able to challenge, influence, and articulate a view and drive behavior or action and train employees Management skills
• Good analytical skills and collaborative style
• Ability to manage and report on projects and drive them to conclusion.
• Self-starter who works with a sense of urgency and acts as a good team player working with other disciplines.
• Adaptability and resourcefulness to roll-up-sleeves and multi-task in order to thrive in a global company environment.
• Effective communications (written and oral)

General:

• All employees must be aware, have knowledge and shall have received general training in Quality requirements of Kelvi. training takes place in the on-boarding process and in New Employee Orientation. More specific Quality training is job specific.
• All training related to the quality management system is done in accordance to the Training Management Process.
• Exercises good use of company funds and property within the set guidelines. Maintains an honest and professional attitude as the company’s representative at all times.
• Contributes to a safe working environment by maintaining own work space and reporting any potential hazards.

Company Description

Start up sports medicine company working with the leading sports teams, athletes, and changing technology for injury recovery.