Quality Systems Specialist

Quality Systems SpecialistDEKA R&D, on behalf of Millyard Advanced Medical Products, is looking for a Quality Systems Specialist to work in a dynamic Medical Device Research and Development environment. The position reports to the Director of Quality. This is a high visibility role with a significant direct impact in the Quality Management System.How you will make an impact:Responsible for documents, records, DCN, and Training processesReview and Approve Quality System RecordsWorks closely with the Quality Systems Manager to implement an eQMS systemCreate, implement, and maintain existing quality system documentation and manage changes to process/product documents, including format and numbering, record retention, change control and document distributionEnsure document accuracy, quality, and integrityProcess changes for QMS Procedures (SOPs)Support updating procedures and processes to support the QMSFile and maintain records manually and electronicallyEstablish, monitor, and respond to metrics on the efficiency of the document management and training processes and its ability to support the businessManage QMS databases for action items and implementationSupport external and internal auditsProvide training as required to DEKA personnelPromote QMS awareness to non-QA departments throughout DEKASkills needed to be successful:2+ years' experience in QMS or document centric environment with degree in Engineering or Science degree/background or 5+ years' QMS or document centric environment without degreeUnderstanding and working knowledge of ISO 13485 and Quality System regulation is requiredProficient in the use of eQMS systems; experience validating eQMS system is preferredExperience with documentation in a regulated field such as medical devicePrior auditing experience is a plusStrong written/verbal communication skillsStrong computer skills, including Microsoft Office applications (i.e., Word, Excel, PowerPoint) and Adobe Acrobat.Ability to:Learn custom software programsMultitask and carry tasks through to completionManage multiple sources of data and develop reportsAbout Millyard Advanced Medical Products:Located in the heart of the Regen Valley in Manchester, NH, our company aims to positively influence the healthcare landscape. Selected Partners:Contract Designer: DEKA Research & DevelopmentContract Manufacturer: Merrimack ManufacturingAbout DEKA:One hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research and Development, where we are taking the same innovation and cutting-edge technology into the modern age.Behind DEKA's brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing. Here at DEKA, some of the most innovative and life-changing products of our time are created, and new ideas are always welcome and explored.