Specialist, Quality Compliance

Job Summary –Support effective quality processes and systems to ensure compliance to applicable Quality System Regulations. Monitor existing processes through tracking, identifying and implementing process improvements. Support the internal and external audit programs as required.General Functions –§ Implement and maintain quality system processes in compliance with GMP/ISO quality standards and assist quality system process improvements projects.§ Facilitate corporate audits and external agency audits including FDA and other certifying bodies, government agencies, alliance partners and consultants. § Correspond with these agencies regarding compliance issues, including GMP and ISO/EN requirements as needed. § Participate in Internal Quality Audits and Supplier Audits to ensure compliance to quality system requirements and to identify appropriate CAPA activity.§ Support and track complaint investigations and resolutions.§ Maintain the complaint handling system and track trend analyses and initiate corrective actions as appropriate.§ Maintain corrective action system and documentation. Support implementation of corrective and preventive actions.§ Assists in the development of new work instructions and training.§ Support existing products and participate on existing product improvement projects.Expected Areas of Competence –§ Proficient knowledge of ISO 9001, ISO 13485, Medical Device Directive and FDA Quality Systems Regulations.§ Experience in implementing and maintaining comprehensive systems to support all applicable requirements. § Strong written and verbal communication and interpersonal skills. § Experienced working on cross-functional teams. § Proficient personal computer skills including electronic mail, project management, record keeping, and routine database activity, word processing, spreadsheet, graphics, etc.Education Requirements – Bachelor’s degree in science or industrial application.Skill Requirements – Minimum one year experience in quality systems.Licenses/Certifications – Quality Auditor certification preferred (ASQ CQA or ISO 9000 Lead Auditor).Travel Requirements – Up to 10%Education: BachelorsJob Level: 1 - 2 yearsPercent Travel: No Travel