Quality Assurance Specialist K2M
THIS JOB HAS EXPIRED The purpose of this position is to assist in the implementation, evaluation, and maintenance of a comprehensive and effective quality and regulatory program that complies with FDA regulations, ISO requirements, and other applicable regulatory bodies or standards.
include the following:
Provide reports to the Quality Director on the status of quality programs.
Direct and when necessary, perform analytical quality assurance tests and interpret the results
Direct and when necessary, perform internal audits of processes, facilities, and documentation to assure compliance with internal procedures, FDA regulations, ISO requirements and other regulatory agencies.
Assist in FDA, ISO and other applicable regulatory assessment audits.
Oversee and assure the operation of the CAPA, PM and/or Training systems.
Write and implement procedures and specifications detailing the aspects of an effective quality system that complies with FDA, ISO and other applicable regulations/standards.
Assist in reviewing, maintaining and upgrading the document control system, i.e. - Master Control.
Assist in performing, reviewing and maintaining Validation Protocol?s and Reports.
Control and oversee maintenance of documentation involved in the Quality system i.e. Device Master Records, Device History Records, CAPA system records, Complaint system records, etc.
Assist with the preparation and review of regulatory submissions for 510(k)?s, technical files and/or other regulatory agencies/countries.
Assist and when necessary, direct, the efforts on process improvement projects.
When necessary, perform label and final inspections.
Assist in monitoring the bioburden and dose audit results for sterile product.
Bachelor?s degree in Engineering or Science preferred
Training in FDA and ISO Quality System regulations and standards.
5 years experience within a manufacturing environment with a working knowledge of quality systems
Strong decision making skills
Proven leadership abilities
Ability to work independently, plan and prioritize
Experience with FDA Class 1 and 2 devices
Experience with ISO 9001 and/or ISO 13485
Experience with TGA, Health Canada, ANVISA and/or JPAL a plus
||751 Miller Drive, SE |
Leesburg, VA 20175
THIS JOB HAS EXPIRED