Provides support in the development and maintenance of company's Quality Systems. Plans and implements Quality Assurance programs designed to ensure continuous production of products consistent with established standards by performing the following duties:
Establishes and maintains Quality Assurance programs, procedures, and controls. Ensures that performance and quality of products conform to established company and regulatory standards.
Supports Quality Control activities (Production, Receiving Inspection, Finished Goods, and Calibration). Helps to meet established schedules or resolve technical or operational problems. Assist in supervisory activities of Quality Control personnel.
Perform non-conformance investigations to determine root case. Assign and ensure completion of corrective and preventive actions. Complete investigations in a timely manner to ensure customer service levels are maintained. Coordinate the reporting and provide trend analysis for non-conformance incidences.
Determines equipment qualification, process validation, and product line design/modifications requirements. Advises Manufacturing on installation and maintenance of inspection and testing procedures for raw materials, packaging materials, components and finished products. Supports design transfer activities.
Works with Manufacturing to provide feedback to production personnel regarding accuracy of assembly procedures. Works with Facilities to establish and maintain effective environmental monitoring systems.
Leads development of Risk Management documentation.
Assists in conducting and documenting process and system audits using specific regulations and company procedures as audit standards.
Promotes and organizes training activities related to product quality, cost, reliability, and regulatory compliance. Develops strategies to ensure continuous improvement in the ability to design and manufacturing quality products.
Maintains an uptodate knowledge in the techniques of Quality Assurance/Quality Control and in the company products and process technologies.
Perform other duties as assigned by supervisor
Strong communication and organization skills required
Good judgment skills within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
Flexibility to handle multiple tasks and meet timelines. Normally receives minimal instructions on routine work, general instructions on new assignments.
Minimum of 5 years experience in an FDA regulated industry.
Experience with problems of diverse scope in which analysis of data requires evaluation of identifiable factors.