Quality Systems Specialist

Our client, Trelleborg Medical Solutions, is looking for a Quality Systems Specialist to support manufacturing processes within a regulated medical device environment.
The Quality Systems Specialist is focused on the maintenance of the Quality Management System (QMS) to ensure compliance with regulatory, quality, company policies and manufacturing requirements.
Tasks and Responsibilities
Quality Systems Specialist Expectations:
Supports all aspects of the internal audit program, ISO notified body audits, customer audits and FDA inspections, including but not limited to:Serve as an auditor for internal auditsCreate and maintain internal audit scheduleAudit controlled document files in preparation for regulatory inspections and provides support during regulatory inspections and client auditsInitiate and execute audits, including developing and documenting the audit plan, leading the audit, generating the audit report, and tracking subsequent actions with the teamProvide support during external audits including scheduling, hosting, preparing audit responsesWork with subject matter experts to ensure audit record content is accurate, well documented, and meets the requirement of the processDevelops metrics and performs trend analysis of key QS areas such internal and external audit findings, CAPAs, nonconforming material, training, deviations, etc. to identify areas for improvement. Escalates trends to an appropriate quality system such as CAPA or CI; presents analysis to managementSupports maintenance of the CAPA programServes as CAPA Owner as needed, driving necessary investigation, correction, and corrective/preventive actionsEnsures all internal and external audit findings are entered into the CAPA system, assigned to the appropriate personnel, and are completed in accordance to the CAPA procedures, within specified time periodsApprove corrective action plans and verify effective and timely implementation of corrective actions for audit nonconformitiesOversees completion and control of customer questionnaires and other customer-required documentsInitiates, facilitates and/or manages projects to expand, change, enhance and improve the quality system, as assignedSupports and coordinates activities related to nonconforming material, complaint/customer feedback, deviations, RMA, and CAPA processesProvides quality system training for the organization as needed Manages review of documents to ensure ISO/FDA compliance of controlled documents lifecycle including annual review managementEnsures all work is performed and documented in accordance with GMP requirements and existing company policies and procedures
Education and Experience
Engineering degree.Knowledge and experience with GMP/ISO Standards: ISO 9000/9001, ISO 13485, and FDA 21CFR 820/11 (4/210/211 as applicable)1 year experience conducting investigations and root cause analysis for complex/advanced issues
English B2+
Desired Qualifications
3+ years of quality/regulatory experience in medical device or related industryISO13485:2016 and/or ISO9001:2015 Auditor Certification4 year degree in Quality, Regulatory, Manufacturing or related field
Benefits
• Subsidized meals• On-site gym• Parking lot• Medical and life insurance