Managing quality systems and ensuring compliance with quality policies at the site is the core of this Quality Assurance Manager role. The position requires a highly hands-on approach, with daily presence on the shop floor, close collaboration with operational teams, and direct involvement in product and process quality. It is suited for a professional who can maintain, improve, and practically apply the ISO 9001 Quality Management System and serve as the primary contact for quality-related matters.
Responsibilities
Take ultimate responsibility for the direction and effective management of assigned departments within the quality assurance function, ensuring each department is resourced, structured, and managed to support organizational goals
Provide input regarding Quality Assurance Program strategy for the site and meet required regulations applicable to managed processes, produced products, and global markets served
Be a key member of the Senior Leadership Team that manages, develops, and drives Merit Medical Systems Inc. to deliver business goals (Best In Class for Safety, Quality, Business Processes; Revenue Growth & New Business Development)
Promote and support the Merit “HEART” Program; lead by example; partner with functional leaders to ensure this program, organizational objectives, and values are at the forefront of decision making and action
Identify opportunities to improve organizational systems and processes to save costs, improve efficiency, maintain compliance, increase product value, or increase customer satisfaction
Provide Merit Medical Systems Inc. with recommendations and decisions which uphold company and regulatory standards in furnishing quality products to the customer
Develop and direct annual “Quality Assurance” team goals to deliver key company objectives and continuous growth of personnel
Review performance of Quality Assurance staff in achieving compliance and system improvement objectives
Prepare or review written procedures and documentation for testing and manufacturing processes
Track information about customer complaints to provide design, development, and operations teams with product quality information
Provide recommendations and decisions regarding the disposition of non-conforming products; determine when Regulatory/Clinical approval is required; stop production lines if problems with quality arise and initiate preventive and corrective actions to ensure non-recurrence
Coordinate Emergency Management Team (EMT) meetings and participate in/manage product investigations
Ensure smooth transition of new products and Technologies to operations groups
Participate, support, and provide independent review of all verification and validation activities
Be the functional and operational manager for a team of quality assurance personnel
Millions of jobs, with real people getting hired every day
200,000+
New jobs added daily
7,000,000+
Verified job listings
1,000,000+
Tailored applications submitted
Resource functional areas and projects with the required resources
Understand the roles of each member of the Quality function in order to drive process improvements
Maintain 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 the team to the benefit of the individuals and the organization, ensuring talent is positioned and utilized for maximum effectiveness
Provide technical support for the manufacture of existing products and the growth and development/transfer of new products/technologies
Perform other related tasks as required
Requirements
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 office 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
Nice to have:
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
Benefits
Flexible working hours
Learning opportunities and internships
About the Company
Merit Medical Systems, Inc., founded in 1987, 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 totaling 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.
