Medartis Inc. - United States · 8 hours ago
Quality Systems Engineer - QMS Focus
Warsaw, IN
Full-time
Onsite
Mid LevelMedartis Inc. is a leading manufacturer and provider of medical devices for surgical fixation of bone fractures. The Quality Systems Engineer will contribute to the Quality Management System team by managing CAPA processes, overseeing audit activities, and ensuring compliance with quality regulations.
Medical Device
Responsibilities
Act as Corrective Action/Preventive Action (CAPA) administrator by facilitating the (CAPA) system. This includes initiating CAPA’s, overseeing timelines, managing the CAPA log, reporting CAPA related metrics and leading CAPA review board meetings to ensure compliance
Manage external audit activities including certification (notified body) audits and customer (contract manufacturing) audits. This consists of taking an active role in the audit process, as well as acting as liaison with external parties, scheduling audits, organizing and facilitating resources, communicating audit responses, maintaining the audit schedule and reporting all audit related metrics
Facilitate all internal audit activities. This includes planning, assigning resources, managing the internal audit schedule, and reporting audit related metrics
Lead Quarterly Quality Reviews (QQR) used to monitor quality management system (QSM) products and process’. Responsibilities include gathering metric data from various parts of the company, scheduling and facilitating the quarterly meeting to measure and review company performance as it relates to the QMS
Gather and manage KPI/metric data used to measure the QMS
Assist quality management representative (QMR) in conducting annual quality management reviews per ISO 13485:2016
Create and/or update procedures and work instructions to capture improvements to quality management system process’
Assist subject matter experts in the development, authoring and releasing of procedures and work instructions used to define their processes
Understand, utilize and assist in maintaining document controls and change controls within the QMS
Ensure processes and documentation comply with quality system regulations
Qualification
Required
BS in Engineering or related field preferred, or equivalent in experience and training
Working knowledge of the medical device regulated industry, to include ISO 13485 and FDA 21CFR820 regulations
Basic knowledge of statistical and engineering principals
Strong analytical and problem solving skills
Strong proficiency in root cause analysis to include tools and methodology
Proficient in Microsoft Office applications
Company
Medartis Inc. - United States
At Medartis, we develop, manufacture and distribute titanium screws and plates, surgical instruments and system solutions for fracture fixation.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase