Provide Plant Quality compliance support for the following Quality tasks and duties: Development, implementation and maintenance of Quality System processes. This will include SOP’s, WI, validation protocols, manufacturing procedures, product & material specifications, development and task force projects. The position will also conduct investigations into complaints, CAPAs, non-conformances, and other site issues related to the Quality System. They will support the transfer of new or improved products/processes into the facilities quality system. This position will also participate in the development, implementation and monitoring of quality programs and policies that ensure that the development, manufacture and distribution of medical products is in compliance with corporate policies, U.S. Food and Drug Administration regulations, ISO 9001, ISO 13485:2003, the Medical Device Directive, the Canadian Medical Device Regulations (CMDR), and other applicable regulatory agencies.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
· Investigate complaints generated from corporate complaints regarding materials within the responsibilities of the Austin manufacturing site.
· Identify, investigate, and implement actions related to non-conformance resolution and CAPA support.
· Facilitate the launching of new or improved products/processes into the site quality system.
· Assisting with the development and coordination efforts for the implementation of new and updated Quality System procedures for ISO/QSR. This will include SOP’s, WI’s, validation protocols, manufacturing procedures, product & material specifications, development and task force projects.
· Develop, review and approve protocols and reports for new and existing products, processes and equipment for the site Quality System. Provide statistical analysis of the data to support the reports.
· Conduct internal audits. Follow up on the status of findings with responsible parties as required
· Participate/support corporate and site projects as assigned
· Ensure that all projects and related documents follow GLP, QSR, ISO or other applicable requirements.
· Support Quality Management Review process through the development, collection, and analysis of quality system data and presenting that to management
· Participate in FDA inspections, ISO Certification and surveillance audits and customer audits.
· Support corporate Regulatory Affairs by providing information for submissions and Annual Reports.
· Identify and implement opportunities for continuous improvement.
· Interact and coordinate activities with other departments, external vendors and customers on projects assigned
· Perform other Quality Systems related duties as required
DESIRED MINIMUM QUALIFICATIONS
· Bachelor’s Degree in Engineering (Biomedical, mechanical, chemical, or electrical) or Science (Biology).
Experience in a Quality Assurance role for medical device or pharmaceutical manufacturing preferred.
· Demonstrate knowledge of medical device manufacturing practices.
· Demonstrates excellent organizational and communication skills and proficiency with the MS Office Suite.
· Must be able to work independently with minimal supervision.
· Able to participate risk analysis including FMEA’s
· Able to prioritize projects and manage Quality Engineering resources to meet organizational goals and objectives
Job Type: Contract