Quality Assurance Supervisor

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