Quality Assurance Supervisor 2nd Shift

Core Quality Functions
•  Record data and maintain accurate records per Current Good Documentation Practices (cGMP).
•  Assist with generating and approving controlled labels using programs provided.
•  Approve lot information during generation of a work order.
•  Assist with First piece approval (FPA) and In-process hourly inspection of finished good product 
according to document specifications.
•  Assist with the operation of various equipment for Seal Integrity equipment.
•  Asist with required in process retain, micro and analytical samples.
•  Retrieval of documents using the EQMS computer system.
•  Review all paperwork daily for accuracy and completeness.
•  Assist in maintaining the quality management system compliance with Regulations.
•  Ensure that the equipment is maintained and records kept.
•  Assist and ensure nonconformances are initiated and reported promptly.
•  Assist in the generation and resolution of corrective and preventive action plans.
•  Ensure equipment is calibrated before use.
•  Assist in maintaining the quality system.
•  Troubleshoot quality concerns that may arise and report to QA Manager.
•  Assist in incoming component, in-process products, and finished products inspection according to 
documented specifications.
•  Retrieved documents from the EQMS system.
•  Written and verbal communication skills are required to communicate issues and procedures among 
multiple departments.
•  Read drawings, templates and other documents.
•  Manage multiple product lines in a time-sensitive environment.
•  As needed, work overtime, weekends, or alternate shifts.
•  Assist in the development and writing of SOPs, Work Instructions, and Forms, as required.
 

Essential Job Skills

•  Knowledge of Current Good Manufacturing Practice (cGMP) Regulations pertaining to medical 
devices and pharmaceuticals.

•  Manage daily activities of QA Technician group to ensure support for business operations.
•  Train QA Technician personnel in all aspects of the quality duties to ensure compliance.
•  Complete performance review and performance documentation for QA Technicians.
•  Ensure paperwork is completed within a timing manner and complies with cGMP.
•  Determine root cause and corrective and preventive action plan for any Investigations, CAPA, and 
OOS issues related to the area of responsibility and complete related documentation.
•  Maintain operational efficiency and compliance with all test equipment and processes.
•  Provide the necessary QA support needed for the rapid commercialization of new products and 
processes.
•  Perform/assist in any required cGMP validations.
•  Ensure the QA Technician are up to date on training to comply with the cGMP.
•  Review in process batch records and equipment notebooks daily.
•  Ability to work with Microsoft Excel, Word, and PowerPoint.
•  Serve as backup for QA Technician when needed.
•  Superior written and verbal communication skills are required to communicate issues and 
procedures among multiple departments.
•  Ability to read and understand drawings, templates and other documents. The ability to use the 
following equipment is desirable:
•  Tensile Machine
•  Burst Test Machine
•  Torque Test Machine
•  Seal Integrity Machine
 

Salary : $70,000 - $75,000