Quality Systems and Compliance Manager

Job DescriptionMGS has an exciting opportunity for an experienced Quality Systems and Compliance Managerto join our MGS Germantown team.The Quality Systems and Compliance Manageris responsible for maintaining and developing the corporate quality system as it pertains to the streamlining and standardization of specific quality activities at each of MGS' Manufacturing locations. Key responsibilities are to support the Director of Quality Systems & Compliance in their efforts to further progress projects across multiple manufacturing sites and regions that increase MGS efficiency, regulatory compliance, quality control and overall alignment to one standard process.Execute Quality department projects to completion with minimal supervisionCommunicate with and influence multiple functional leadersManage the document control software and apply best practicesExecute Internal Audits in compliance with ISO14001, ISO9001, or 13485 (as applicable) and corporate policies.Assist with external audits from Regulatory bodies or customersCollaborate on corrective action plans related to audit findingsUnderstand workflows and approval cycles for controlled documentsCompose procedures, SOP, Work Instruction or Policies that have a multi-site impactReview and approval of corporate quality system documentsManage the project rollout of new e-QMS modules across multiple sitesSupport with the onboarding or ramp of new sites in relation to preparing the site for inspection and commercial activities, including QMS and records review.Manage all records related to the Corporate Quality system.Report on project updates and QMS software analyticsAnalyze manufacturing quality processes such as batch release, CAPA, Hold Material and validation in order to recommend improvementAny other duties as assigned.About MgsAs a global provider of healthcare manufacturing solutions, MGS provides the right balance to drive vital innovations: robust end-to-end solutions combined with the strong customer focus and seamless collaboration of an agile partner. That's why we're the engineering and manufacturing partner of choice for today's leading Pharma, Diagnostic and MedTech innovators. Serving customers from 12 strategically located facilities around the world, we transform our customers' most pressing challenges into innovations that improve lives. To learn more about MGS, please visit www.mgsmfg.com.Required ExperienceA qualified Quality Systems and ComplianceManagerwould fulfill these requirements:Completion of a bachelor's degree in Pharmaceutical, Medical Device, or engineering discipline.Experience with Quality System Management, ideally ISO13485At least 5 years' experience working within a Quality systems, project or day to day quality role within a regulated manufacturing environmentProficient in Microsoft Office ApplicationsProfessional verbal and written communicationExcellent attention to detail and accuracyAbility to multi-task and prioritizeAbility to read, write, comprehend, and communicate the Spanish language in a proficient manner is preferred.MGS is an Equal Opportunity Employer.BenefitsWe offer an excellent benefits package including medical, dental, vision, 401K, disability, life, FSA, vacation, and holidays.Keyword: Quality Systems and Compliance Manager