Senior Director,Quality Assurance Job South Jordan area,Utah USA,Quality Assurance

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 optimise overall operational efficiency and effectiveness while maintaining & developing best in class quality systems.

ESSENTIAL FUNCTIONS PERFORMED

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)

Serves as the assigned Quality System Management Representative for Merit Medical Systems Inc.; primary regulatory agency and customer contact on all quality related queries such as 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).

Key member of Senior Leadership Team that manages, develops and drives Merit Medical Systems Inc. to deliver the goals of the business (Best In Class Safety, Quality, Business Processes, Revenue Growth & New Business Development).

Promotes, supports the “Merit Business Excellence System” Program; leads by example; partners with functional leaders to ensure the program, the organization’s 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.

Partners 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

Participates, supports and provides independent review of all verification and validation activities.

Functional manager for a team of quality assurance personnel: resource functional areas, projects with the required…

Senior Director, Quality Assurance