Senior Director, Quality Assurance

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

DAY (United States of America)

SUMMARY OF DUTIES

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.

ESSENTIAL FUNCTIONS PERFORMED

1. 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. Departments may include, but are not limited to:

• Calibration
• CAPA
• Compliance
• Customer Relations
• Document & Data Control
• Internal / External Quality Audit
• Management Review
• Quality Control, Product Release
• Quality Engineering
• Quality Inspections
• Risk Management
• Supplier Quality (Including selection & inspection Methods, incoming materials)
• Validation (Product & Process)

2. 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.

3. 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).

4. 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.

5. 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.

6. Identifies opportunities to improve organizational systems and processes to save costs, improve efficiency, maintain compliance, increase the value of products, or increase customer satisfaction.

7. Develops capital plans and budgets for the Quality Operations Department.

8. 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.

9. Provides technical support for the manufacture of existing products and the growth and development / transfer of new products / technologies.

10. 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

11. Participate, support and provide independent review of all verification and validation activities.

12. 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

13. Deputise as for Vice President, Global Quality Assurance as directed.

14. Perform other tasks as required.

ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS

• Lifting -- Not to exceed 50 lbs. - local practice may apply.
• Writing
• Sitting
• Standing
• Bending
• Visual Acuity
• Color perception
• Depth perception
• Reading
• Field of vision/peripheral
• Fine motor skills

SUMMARY OF MINIMUM QUALIFICATIONS

• 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.

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.

COMPETENCIES / EXPECTATIONS

• 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.

COMMENTS

Infectious Control Risk Category II:

The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category I states employment and procedures that will require exposure.

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.