JOB SUMMARY:

This position is responsible for supervising the day-to-day inspection activities of incoming material and in-process and final products to ensure product specifications are met in addition to managing the returned and nonconforming materials processes to ensure timely completion of all activities as required by governmental regulations. 

ESSENTIAL RESPONSIBILITIES & ACCOUNTABILITIES:

• Supervise the daily activities and assignments of the quality control team to include 1) quality inspections, i.e., incoming, in-process and final, 2) receiving, documenting, processing and moving returned good and products in the RMA system, 3) managing the nonconforming material process and conducting MRB meetings, as required, to ensure compliance to quality standards and governmental regulations, i.e., FDA QSR, ISO 13485, Canadian Medical Device Relation.
• Act as liaison between the Warehouse/Manufacturing and QA departments.  Provide feedback on accuracy of CIS and QIR’s to ensure they are current and revise as necessary.  Ownership of KPI (key performance indicators) tracking for the QC team. 
• Participate in facility and QSR inspections by the Food and Drug Administration (FDA), Notified Body and internal GMP audits.
• Interact with multi-functional groups inside and outside the Quality department.
• Train QC inspection staff members on quality procedures. 
• Evaluate employees through performance reviews, ongoing coaching and feedback methods.
• Provide quality data, trending/statistical reports to the Quality System Supervisor/Quality Manager.
• Participates in special projects and performs other duties as required.

In addition to the essential duties and responsibilities listed above, all positions are also responsible for:

• Meeting company standards pertaining to quantity and quality of work performed on an ongoing basis, performing all work related tasks in a manner that is in compliance with all Company policies and procedures including Worldwide Business Standards.
• Adhering to Company policies, procedures, and directives regarding standards of workplace behavior in completing job duties and assignments.

PHYSICAL ACTIVITIES / WORK ENVIRONMENT:

This position will be working in an office environment, utilizing typical office equipment. While performing the duties of this job, the employee is regularly required to stand; use hands and fingers to handle, or feel product; reach with hands and arms.  The employee is occasionally required to walk; stoop, or kneel, and talk and hear.  The employee must occasionally lift and/or move up to 10 pounds.  Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus. While performing the duties of this job, the employee may be exposed to moving mechanical parts.  The noise level in the work environment is usually moderate.