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.

WORK SHIFT

SUMMARY OF DUTIES

SUMMARY OF DUTIES

Quality Management System process owner with primary responsibility for documenting, training, executing, measuring, and improving process compliance for the quality management sub-systems assigned.

ESSENTIAL FUNCTIONS PERFORMED

Responsible for the following quality management sub-systems:

• Global Quality Metrics

• Global Management Review

• Quality Systems Software Validation

• Global External Audit / Regulatory Certification Leader (Notified Body Laison)

• Responsible for overall global process definition, format, validated data sources, data accessibility and statistical methodologies used to support Global Quality Data Systems and measure Global Quality Key Performance Indicators (KPI).

• Harmonizes Quality Data and KPI accessibility and reporting to assure consistency, accuracy, and data integrity.

• The Global Quality Data Systems harmonization should include but is not limited to the same or substantially equivalent KPI structure, data ranges, statistical methods, measurement scales, reporting format, and should clearly represent goals, targets and objectives.

• KPI format, where possible, should be consistent across process reporting mechanisms including Site and Global Management Reviews.

• Documents, implements, and maintains compliant quality management sub-systems to assure effective operational execution of assigned responsibilities across all Global sites and locations.

• Evaluates, implements and continuously improves manual or electronic tools and systems to support timely and effective completion of required deliverables.
  Provides Subject Matter Expertise and Training / development requirements and objectives for assigned areas of responsibility.

• Works in close collaboration and partnership with cross functional and cross Site Global Quality Assurance stakeholders to optimize overall operational efficiency and effectiveness while maintaining & developing best in class quality systems.

• Manages the Global Management Review (MR) process including but not limited to the MR schedule, review content, meeting minutes, follow up actions, compliance records and communication to Global Team and Stakeholders.

• Compliance responsibility for quality management system data sources and electronic tools (including Global Enterprise Software Applications) to assure that systems and tools are appropriately validated in accordance with all applicable international regulatory standards and regulations.

• Global Quality point of contact for maintaining external Quality Management System Certifications.

• Coordinates and manages external audit schedules.

• Responsibilities include but are not limited to management and coordination of audit related efficiency and harmonization objectives, audit related cost estimates, purchase orders, invoice approvals and audit related budget inputs, audit preparation, required support resources, and internal coordination and communication.

• Performs other duties, 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 five (5) years of work-related experience, of which a minimum of three years' experience in a related supervisory, leadership or management role.

• Proven track record in leading organizations through external inspections / audits / QMS and Product related certifications / assessments (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.

PREFERRED QUALIFICATIONS

• Post graduate diploma/Master's degree in Quality Management or Electronic Data Management Systems / IT related disciplines.

• 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.

COMPETENCIES

• 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 workflows. Presents numerical data effectively. Attention to detail without losing sight 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 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.

As an eligible Merit employee, you can expect the following:

* Multiple Shifts and Hours to choose from: Days, Swing (Eve), and Nights

* Medical/Dental & Other Insurances (eligible the first of month after 30 days)

* Low Cost Onsite Medical Clinic

* Two (2) Onsite Cafeterias

* Employee Garden | Gardening Classes

* 3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays

* 401K | Health Savings Account

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

Military Veterans are encouraged to Apply.

Merit is a proud Utah Patriot Partner committed to hiring our Veterans.