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)
Supplier quality management requirements and techniques
Inspection methods and test method validation
Ability to work within a team environment and build relationships inside and outside of the Quality department as well as with teams outside the company.
Collaborate effectively across the organization, leverage resources from other parts of the organization to build commitment and achieve results.
Results oriented with the ability to deliver and meet deadlines.
Strong knowledge of statistics, process control, and process capability techniques.
Strong communication skills.
Proven ability to direct, build, develop and manage a team of professionals.
Interpret engineering drawings and specifications.
Knowledge of applicable government specifications, standards, and regulations such as Quality System Regulation, MDSAP, and ISO 13485.
Education/Experience Requirements
This position requires a Bachelor's Degree in engineering or a related discipline with 6-8 years of work experience in quality functions, or an advanced degree (ex. Masters) in a related discipline with 4-6 years of experience in quality functions.
Must be experienced in all aspects of quality control methods such as nondestructive testing, metrology, statistical process control, quality cost accounting, applied statistics and inspection.
Experience in dealing with representatives from Food and Drug Administration or other regulatory agencies.