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…