Senior Director, Quality Assurance

Merit Medical Systems•South Jordan, UT

5d•Onsite

About The Position

Develops, interprets, and implements quality policies, manages quality systems, and facilitates compliance at the respective site(s), regions or globally. Works in close collaboration and partners 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.

Requirements

Education and/or experience equivalent to a Bachelor’s Degree in Quality Engineering/Engineering/ Science/Materials Science/Biomedical Engineering or equivalent qualification essential (NFQ Level 7, or higher).
At least ten years of work-related experience, of which a minimum of four years’ experience is in a related management role.
Proven track record in leading organizations through external inspections / audits (e.g. FDA, Notified Bodies, 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 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 the ability to understand and learn customized computer software programs.
Strong leadership ability and the ability to influence at all levels within the organization.
Demonstrated leadership skills including the ability to coach, assess, evaluate, develop, motivate and empower others.
Ability to provide functional, cross functional and organizational leadership as required by the demands of the role.
Excellent communication (oral and written) and interpersonal skills with the ability to convey information and ideas in a variety of media, tactful, confident at all levels, internal and external.
Excellent data, analysis, trends, and reporting skills. Ability to read and interpret documents. Ability to write clearly and informatively technical documentation, routine reports, correspondence, procedures and work flows. Presents numerical data effectively. Attention to detail without losing site of the big picture.
Identifies and resolves problems in a timely manner; develops alternative solutions; works well in group problem solving situations; presents ideas and information in a manner that gets others' attention; displays willingness to make decisions; exhibits sound and accurate judgment; supports and explains reasoning for decisions includes appropriate people in the decision-making process.
Strong project management skills, including the ability to prioritize, balance, and manage multiple efforts with strong results/goal orientation.
Demonstrates organizational values in carrying out of all assigned responsibilities/tasks.

Nice To Haves

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.

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. May have functional responsibility and oversight for quality assurance at other divisions.
As applicable, assigned Quality System Management Representative for Merit Medical Systems Inc.; primary regulatory agency and customer contact on all quality related queries e.g. compliance audits & follow up, customer complaints, quality agreements, and technical agreements.
Instrumental in setting strategy to enhance and maintain Merit Medical Systems Inc. Global Quality Assurance Programs, to meet the required regulations applicable to the processes managed, products produced, and global markets served e.g. US, South America, Canada, EMEA, APAC, CSR (Customer Specific Requirements).
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 Business Excellence System” 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.
Develops capital plans and budgets for the Quality Operations Department.
Provides Merit Medical Systems Inc. with recommendations and decisions which uphold company and regulatory standards in furnishing quality products to the customer by: Developing and directing annual ‘Quality Operations" team goals to deliver the key company objectives and continuous growth of personnel. Reviewing performance of Quality Operations staff in achieving compliance and system improvement objectives. Preparing or reviewing written procedures and documentation for Quality System Processes, 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 and/or product shipments 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.
Provides technical support for the manufacture of existing products and the growth and development / transfer of new products / technologies.
Partner with Research and Development (Product & Technology) function ensuring: Customer requirements are met, Safe and effective product design, Compliance with design control requirement, Design for manufacture, Quality at source, Smooth transition of new products and Technologies to operations groups.
Participate, support and provide independent review of all verification and validation activities.
Functional manager for a team of quality assurance personnel: Resource functional areas, projects with the required resources. Select, coordinate assigned work, mentor, 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.
Deputise as for Vice President, Global Quality Assurance as directed.
Perform other tasks as required.