| Job Summary: |
| The QC Supervisor Level 2 is responsible for performing a wide variety of tasks involving supervision of incoming, in-process and finished product inspection of raw materials and assembled medical devices. He/she is responsible for executing the QC plan set by the QC Manager for his/her shift. This includes inspection equipment set-up and change-overs, timely inspection of materials, directing QC technicians, and supervising/conducting quality checks. As required, he/she will work along-side inspection technicians in work that requires manual dexterity, visual acuity and speed to perform the task at the required rate. He/she is also responsible for ensuring that all QC technicians follow specific written work instructions and providing training and corrective feedback, when required. He/she will record quality-related data and information. Duties will also include assuring QC areas are properly maintained, inspection equipment is within calibration and that areas are cleared for inspection to avoid mix-ups |
| Essential Job Functions: |
| · Supervisory Role: Supervise QC technicians to ensure proper job performance and provide training. Provide positive and corrective feedback to QC technicians on meeting expectations for inspection, quality, safety, on-time delivery, waste and attendance. Monitor and report all inspection-related activity. Ensure that material inspections are completed on time and according to specifications and all applicable SOPs and work descriptions. Maintain order and cleanup of assigned work area.· Quality Assurance: Coordinate Quality Assurance checks and lin clearances with shift Quality Inspector or perform Quality Assurance procedures to ensure consistent product quality and safety. Document according to SOPs.· Maintenance: Supervise or conduct complete inspection equipment change overs and equipment set-up as required to conduct timely inspections. Coordinate preventive maintenance with Maintenance Manager to ensure proper operation and calibration of inspection equipment. Continually monitor environmental systems to ensure clean rooms are operating within environmental specifications.· Continuous Improvement: Support continuous improvement of all inspection processes by coaching team members to improve performance within the company QMS system, identifying opportunities for improvement, soliciting ideas from team members on how to improve processes, and implementing approved ideas. Report progress on quality, safety, delivery, waste and attendance and other key measures in accordance with report schedule set by operations management. Provide feedback on shift results to team members and make recommendations for improvement. Report and address any conditions or actions that are inconsistent with safe and effective operations.· Support QC Manager: Support QC Manager by reacting to change productively, accepting additional assignments positively and controlling rumors or negative comments or behaviors. Act as a positive example to workforce. |
| Education/Experience Required: |
| High school diploma or GED required. 10 years on-the-job training and experience as a supervisor of QC employees required. College degree preferred. Computer skills in MS office products, including Word, EXCEL and database programs are required. Familiarity with and certification in Six Sigma, LEAN manufacturing or other vigorous quality control programs are highly desirable. Applicable ISO and FDA experience is highly desirable. QC Supervisors are responsible for providing leadership on shift to QC employees, handling emergency inspection needs and planned equipment change-overs, performing quality assurance functions, handling emergencies calmly, resolving conflicts among QC employees and enforcing performance standards, as well as working with QC employees in work that involves visual and physical inspection. QC Supervisors must be able to read and understand all written instructions, communicate well with others, and have excellent vision and manual dexterity. The ability to work in a clean room environment is an essential job function, as is the ability to communicate effectively orally and in writing with the entire workforce. The ability to perceive all aspects of the work environment, product and component samples and documentation is essential. This position requires attention to detail, excellent time, people and document management skills and the drive to complete and follow-through for completeness. The ability to handle multiple priorities in a fast changing work environment is essential, as is positive interaction with others and reliable attendance. |
| Physical/Mental Demands of Job: |
| Posture |
|
| Standing |
|
20 |
% of time |
Standing to operate equipment and perform quality test functions. |
| Walking |
|
15 |
% of time |
Walking throughout facility to monitor activity. |
| Sitting |
|
65 |
% of time |
Sitting to operate equipment, prepare reports and perform inspection |
| Strength |
|
| Lifting |
|
50 |
Lbs for |
|
Material handling functions. |
| Carrying |
|
50 |
Lbs for |
|
Material handling functions. |
| Pushing |
|
100 |
Lbs for |
|
Material Carts |
| Pulling |
|
100 |
Lbs for |
|
Material Carts |
| Stooping |
|
|
Performing area cleanup, maintenance, and equipment changes. |
| Reaching |
|
|
Performing inspection operations and equipment change-overs. |
| Dexterity |
|
|
Performing quality testing. |
| Oral |
|
|
Must be able to communicate orally with coworkers. |
| Auditory |
|
|
Must be able to understand oral instructions and perceive working environment and emergencies. |
| Vision |
|
|
Perform inspection operations, observe QC employees, perform quality tests, perform equipment maintenance and change-overs. |
| Color |
|
|
Must be capable of distinguishing product types and defects. |
| Depth Perception |
|
|
Performing inspection operations, equipment maintenance and change-overs. |
| Conduct and attendance |
X |
|
Must be able to maintain self-control in challenging circumstances and be very reliable in attendance and punctuality. |
|
|
