Quality Assurance Engineer III; Sensors

Position: Quality Assurance Engineer III (Sensors)
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 and/or region.

Assigned site Quality System Management Representative; responsible for providing support to ensure product is manufactured to the required regulations, standards and specifications; primary customer contact on all quality related queries e.g. compliance audits & follow up, customer complaints, quality agreements, and technical agreements.

Works in close collaboration and partnership 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. Departments may include, but not limited to:

* Calibration

* CAPA

* Compliance

* Document & Data Control

* Design Assurance

* Environmental Control

* Field Assurance

* Risk Management

* Internal / External Quality Audit

* Quality Control, Product Release

* Management Review

* Quality Inspections

* Quality Engineering

* Real Time Aging

* Supplier Quality

* Validation (Product & Process)

2.May be assigned Quality System Management Responsibilities for Merit Medical Systems Inc at the site and/or region; may be primary regulatory agency and customer contact on all quality related queries for the site e.g. compliance audits & follow up, customer complaints, quality agreements, and technical agreements.

3.Provides input regarding Quality Assurance Program strategy for the site and/or region and meets the required regulations applicable to the processes managed, products produced, and global markets.

4.Key member of the Management Team that manages, develops and drives Merit Sensor 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 Assurance Department.

8.Provides Merit Sensor Systems Inc. with recommendations and decisions which uphold company in furnishing quality products to the customer by:

* Developing and directing annual 'Quality Assurance" team goals to deliver the key company objectives and continuous growth of division.

* Reviewing performance of Quality Assurance division in achieving compliance and system improvement objectives.

* Preparing or reviewing written procedures and documentation for 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; stops production lines 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 of new products / technologies.

10. Partner with Research and Development (Product & Technology) function…