Contract Quality specialist

Position Summary:This position supports the Quality Management System ensuring compliance to relevant regulations and standards including ISO 13485:2016 and FDA QSR Part 820. The focus for this position is document and record control, internal audit support, training system(s), procedural development for compliance to regulation, and continual process improvement within Quality Management Systems.• Maintain device master files.• Manage internal audit schedule, support internal audits and track action item closure and effectiveness per ISO 13485.• Ensure compliance with record retention per corporate policy for device master files; support record control activities• Ensure regulations and standards are available and current within the Quality System; revise procedures as needed.• Integrate training feedback process and "knowledge check" per ISO 13485:2016. • Develop appropriate training when processes have been revised, maintain training records. • Maintain and improve the review process for procedure (SOP) lifecycle.• Support CAPA process; track action item closure and adherence to procedural requirements for Corrective Action/Preventative Action.Minimum Requirements/Qualifications:HS diploma or equivalentQuality Systems Regulations experience requiredExperience in a manufacturing environmentProficient in MS applications (Excel, Word, Outlook)Excellent communication and attention to detailAbility to work independently and as part of a team, self-motivated with a positive attitudeMust demonstrate strong organizational skills and be able to handle multiple assignments simultaneously