Quality Lead

Job Description   

Division:  Healthcare              Location:  South Madison Plant 

Job Title: Lead Person- Quality   

Department: Manufacturing Department/Facility   

Reports To: Quality Manager   

Prepared by:  Human Resources

Summary/Purpose:  A team leader, planner, trainer, and administrator. Must continually support and demonstrate a bias for action on individual and/or employee team based initiatives.  Encourages employee participation in our improvement processes by demonstrating proactive support for team based initiatives.    

 Essential Job Responsibilities and Duties: ��

Reference: Classification Matrix for detailed skills/tasks required.     

Promotes personal and product safety by:  

Constantly accessing job requirements and addresses possible job hazards by either eliminating the hazard or through implementing a requirement for PPE or possible engineering solution.  

Audits employee behaviors to ensure compliance with safety rules and guidelines.  

Drive floor level safety compliance and implement safety initiatives.  

Participates actively on the plant-wide safety teams.  

Ensures Quality of products and processes are maintained by:  

Understands and supports the quality policies, quality systems. Reports any non-conformances or high risk quality problems to immediate supervisor.  

Reject any non-conforming material 

Block material use in PRMS

Disposition 

What to do with RJM 

Rework or scrap material 

Communicate with Vendors if needed in SCAR process. 

Leads daily activities of quality area to ensure that volume, safety, and quality standards are achieved.   

Identifies problems related to quality process and provides quality reports to assist process improvement.  

Create and/or adjust WI and SOPs as needed based on process improvements and adjustments. 

Responsible for the training and development of personnel.  

Monitor and update training records and needs of all plant personnel in Intelex. 

Reviews employee performance periodically and provides feedback to supervisor for continuous improvement.   

Ensures that data collection/reporting activities within the Quality department are completed accurately and on a timely basis.   

Record keeping 

Must file all certificates in a timely manner 

Ensure verifications are completed in a timely manner 

Maintain and schedule calibrations on equipment with outside calibration companies. 

Customer Relationships 

Preparing COA (certificate of analysis) and documenting  

Lead and direct customer investigations if complaints arise 

Preparing Samples for customers if needed 

Handle Urgent Requests for customers via proper communication channels  

Works closely with Manufacturing Process Engineer and QA in the development and implementation of Statistical Process Control.  

Facilitates team improvement projects such as, but not limited to:  

Quality improvement- implementation of Statistical Process Control.  

Waste Reduction  

Compliance with Good Documentation Practice 

Procedural compliance 

 

Work with QC Manager and Technical Manager on new products, samples and issue resolution.  

Actively participates and encourages direct reports to participate in root cause investigations and process improvement teams.  

Capable of working nights, either 2nd shift or 3rd shift as well as weekends as necessary.  

Additional tasks assigned by department management. 

 

Job Qualifications, Equipment and/or Experience:  

  

2-4 years' experience in Quality Technician role 

In good standing with attendance 

Demonstrated team facilitation skills and success in implementing process improvements in conj