Supervisor, Quality

Argon Medical Devices Inc•Athens, TX

About The Position

Responsible for all aspects of Quality processes, including supervising department personnel and managing the daily scheduling of quality activities to ensure accurate and efficient inspections, testing, checks, and sampling of incoming and in-process materials, components, and subassemblies used in the manufacture of medical devices. Conduct inspections of sterilized products, as applicable, and perform comprehensive reviews of Device History Records (DHRs) to support the release of finished goods.

Requirements

Bachelor's Degree from a four-year college or university; or 5 + years of related experience and/or training; or equivalent combination of education and experience.
2+ years of supervisory experience
Must be able to Interface with personnel both Inter and Intra departmental to support the most efficient process for product introduction.
Excellent PC skills in a Windows environment, specifically Word, Excel, and Access.

Nice To Haves

Experience in inspection techniques and gage usage a plus
Experience using QAD or similar MRPS software

Responsibilities

Develop and train employees to perform jobs correctly and to inspect products efficiently while keeping all required work-related records up to date.
Perform inspections of purchased parts, subassemblies or finished company products according to well defined criteria using standard physical, mechanical and/or electrical measurements while maintaining a steady workflow.
Rework or reject subassemblies or finished products as required.
Accurately document the results of the Inspections and testing and assist In the writing and updating inspection procedures, protocol, and checklists.
Maintain all controlled document files and test records In a timely and accurate manner.
Coordinate calibration of all test equipment and fixtures with Calibration department.
Monitor critical equipment and Instrumentation to ensure proper operation and calibration.
Maintain organized product hold cage.
Participate in the construction and/or revision of procedures for the Inspection function.
Evaluate problems and make recommendations for possible corrective action to supervisor.
Perform review of Device History Records and other documentation for compliance to established procedures and Good Documentation Practices.
Follow all safety procedures.
Monitor and train Incoming quality employees to the core requirements of their positions.
Serve as communication link between management and the department to ensure quality Information flow.
Provide effective leadership and coaching to department members, including goal setting and performance feedback.
Other duties as assigned.
Maintain staff job results by coaching, counseling, and disciplining employees.
Plan, monitor, and appraise job results.
Schedule and organize staff to accommodate anticipated workflow for optimum efficiency of department.
Maintain an environment of fairness, challenge, and support to foster job effectiveness and a sense of direction and well-being in department employees.
Respond to all employee concerns in a timely and efficient manner.
Monitor and update procedures to improve efficiency of department.
Must be able to prioritize conflicting priorities and accomplish required tasks.