Senior Quality Assurance Manager

Job Summary :

The Sr. Quality Assurance Manager is responsible for Quality and Compliance activities at Highridge Medical’s Mississippi and Colorado sites. The incumbent provides technical and administrative guidance to the Quality Assurance, Calibration, Quality Engineering, and Supplier Quality Engineering teams at these two sites. The incumbent is responsible for ensuring that the processes used to produce and control products are compliant to the applicable regulations as well as ensuring product conformance to established requirements and standards through appropriate inspection and test activities for raw materials and finished medical devices. The incumbent has primary responsibility for assuring compliance with Supplier Quality Management processes, Production and Process Controls, Product Release, Nonconforming product, CAPA, internal / external audit management, metrics, and resource allocation needed to achieve on-time and within budget quality activities.

Principal Duties and Responsibilities :

• Manage all supplier quality related activities including supplier qualifications, scorecards / monitoring of supplier performance, SCARs, and audits.
• Formulate, write, and maintain procedures, specifications, and standards for the quality control of products including non-destructive testing methods, gauge design and procurement, sampling and inspection methods and visual acceptance standards.
• Coordinate the maintenance of the calibration program for all inspection tools and gauges per company procedures.
• Develop and administer effective data collection, monitoring, and reporting systems to meet regulatory requirements and drive continuous improvement.
• Control further processing, delivery, or use of nonconforming products until deficiency or unsatisfactory condition has been corrected and ensure escalation to CAPA or SCAR as appropriate.
• Implement defect prevention strategies utilizing SPC / SQC principles and practices.
• Maintain quality systems and manage audits / inspections such as FDA, Notified Body, and internal audits.
• Ensure that the design transfer process is completed appropriately, that the suppliers and sites are prepared to accept the new design and monitor the quality of the design transfer.

This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA.

Expected Areas of Competence (i.e., knowledge, skills, and abilities)

Education / Experience Requirements

Travel Requirements

Up to 10%

Salary : $119,000 - $157,000

Salary : $119,000 - $157,000