Quality Assurance Manager

Why Merit?

At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world.

SUMMARY OF DUTIES

Develops, interprets, and implements quality policies, manages quality systems, and facilitates compliance at the site. Responsible for maintaining, improving, and practically applying the ISO 9001 Quality Management System at the site.

This role is highly hands-on, requiring daily presence on the shop floor, close collaboration with operational teams, and direct involvement in product and process quality. The Quality Manager acts as the Quality System Management Representative, ensures compliance with ISO 9001, and serves as the primary contact for customers and external auditors on all quality-related matters.

The Quality Manager works closely with Production, Logistics, and Leadership to ensure that quality is embedded in daily operations and that the QMS remains practical and effective.
Works in close collaboration and partnership with Global Quality Assurance Team, other divisions, departments and functions, to optimize overall operational efficiency and effectiveness while maintaining & developing best in class quality systems.

DUTIES & RESPONSIBILITIES

• Takes ultimate responsibility for the direction and effective management of assigned departments within the quality assurance function, ensuring that each department is resourced, structured and managed to support the goals of the organization
• Provides input regarding Quality Assurance Program strategy for the site and meets the required regulations applicable to the processes managed, products produced, and global markets served.
• Key member of Senior Leadership Team that manages, develops and drives Merit Medical Systems Inc. to deliver the goals of the business i.e. Best In Class (Safety, Quality, Business Processes), Revenue Growth & New Business Development.
• Promote, support the Merit “HEART” Program; lead by example; partner with functional leaders to ensure that this program, the organizations objectives and values are at the forefront of decision making and action.
• Identifies opportunities to improve organizational systems and processes to save costs, improve efficiency, maintain compliance, increase the value of products, or increase customer satisfaction.
• Provides Merit Medical Systems Inc. with recommendations and decisions which uphold company and regulatory standards in furnishing quality products to the customer
• Developing and directing annual ‘Quality Assurance” team goals to deliver the key company objectives and continuous growth of personnel.
• Reviewing performance of Quality Assurance staff in achieving compliance and system improvement objectives.
• Preparing or reviewing written procedures and documentation for testing and manufacturing processes.
• Tracking information about customer complaints to provide design, development and operations teams with product quality information.
• Providing recommendations and decisions regarding the disposition of non-conforming products; determines when Regulatory/Clinical approval is required; stops production lines if problems with quality arise and initiates preventive and corrective actions to ensure non-recurrence.
• Coordinating Emergency Management Team (EMT) meetings and participates/manages product investigations.
• Smooth transition of new products and Technologies to operations groups
• Participate, support and provide independent review of all verification and validation activities.
• Functional & operational manager for a team of quality assurance personnel:
• Resource functional areas, projects with the required resources.
• Understanding of the roles of each member of the Quality function in order to drive process improvements.
• Maintains daily visibility on the shop floor to monitor processes, support employees, and identify quality risks.
• Select, coordinate assigned work, mentor, coach, manage performance for all team members ensuring appropriate corrective action for sub-optimal performance, and recognition of strong performance creating avenues for advancement.
• Manage training and career developmental needs of team to the benefit of the individuals and the organization, ensuring that talent is positioned and utilized for maximum effectiveness
• Provides technical support for the manufacture of existing products and the growth and development / transfer of new products / technologies
• Perform other related tasks as required.

SUMMARY OF MINIMUM QUALIFICATIONS

• Education and/or experience equivalent to a Bachelor’s Degree in Quality Engineering/Engineering/ Science, or equivalent qualification essential (NFQ Level 7, or higher).
• At least nine years of work related experience, of which a minimum of four years’ experience in a related management role.
• Proven track record in leading organizations through external inspections / audits (e.g. FDA, Notified Bodies, Regulatory Agencies, Competent Authorities, and Customers).
• Working knowledge of and experience with U.S. FDA regulations, the Medical Devices Directive (93/42/EEC), Medical Device Regulation MDR EU 2017/745, ISO 13485 Quality System Standard, Medical Device Single Audit Program, ISO 14971 Risk Management, Canadian Medical Device Regulation (CMDR), ANVISA, TGA and JPAL/JGMP.
• General knowledge of the medical device industry and the applications of Merit's products in the medical field.
• PC skills including standard offices packages as well as ability to understand and learn customized computer software programs.
• Excellent communications skills to include oral and written fluency in English and local language as deemed appropriate.

PREFERRED QUALIFICATIONS

• Post graduate diploma/Master’s degree in Quality Management.
• Demonstrated aptitude for process improvement and use of Lean and Six-Sigma resources and tools.
• Strongly prefer medical device manufacturing management experience.
• Strongly prefer proven track record leadership experience in the development of a large, international team, in multiple regions. 

We are Global

Founded in 1987, Merit Medical Systems, Inc. is a leading manufacturer and marketer of proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy. Merit serves client hospitals worldwide with an international sales force and clinical support team totalling in excess of 500 individuals. Merit employs approximately 6,300 people worldwide.

Merit Medical EMEA currently has over 300 employees, spread over more than 20 countries in the EMEA region.

Merit Maastricht (The Netherlands) is the European Headquarters and Distribution Center of Excellence. Much of Merit Medical’s world-class customer service happens here along with our excellent physician training courses. More than 100 employees work at this growing Merit campus and enjoy many benefits, such as flexible working hours and competitive salaries as well as learning opportunities and internships.

Culture

A supportive and collaborative environment make Merit Medical a friendly, enjoyable place to work. We are proud of our energetic and dynamic culture. Diversity & Inclusion is evident here with a 50/50 ratio of male and female employees and more than 30 nationalities. We value every employee as an individual.

To see more on our culture, go to www.merit.com/careers.