Quality Systems and Compliance Manager

Job Description MGS has an exciting opportunity for an experienced Quality Systems and Compliance Manager to join our MGS Germantown team. The Quality Systems and Compliance Manager is 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 supervision Communicate with and influence multiple functional leaders Manage the document control software and apply best practices Execute internal audits in compliance with ISO14001, ISO9001, or ISO13485 (as applicable) and corporate policies Assist with external audits from regulatory bodies or customers Collaborate on corrective action plans related to audit findings Understand workflows and approval cycles for controlled documents Compose procedures, SOP, work instructions or policies that have a multi‑site impact Review and approval of corporate quality system documents Manage the project rollout of new e‑QMS modules across multiple sites Support the onboarding or ramp of new sites in preparation 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 analytics Analyze manufacturing quality processes such as batch release, CAPA, hold material and validation to recommend improvements Any other duties as assigned About MGS As a global provider of healthcare manufacturing solutions, MGS delivers robust end‑to‑end solutions combined with a strong customer focus and seamless collaboration of an agile partner. 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 their most pressing challenges into innovations that improve lives. To learn more, visit Qualifications Required experience and qualifications: Completion of a bachelor's degree in pharmaceutical, medical device, or engineering discipline Experience with quality system management, ideally ISO13485 At least 5 years of experience working within a quality systems, project or day‑to‑day quality role within a regulated manufacturing environment Proficient in Microsoft Office applications Excellent verbal and written communication skills Excellent attention to detail and accuracy Ability to multi‑task and prioritize Preferred: ability to read, write, comprehend and communicate in Spanish Benefits We offer an excellent benefits package including medical, dental, vision, 401(k), disability, life, FSA, vacation, and holidays. MGS is an Equal Opportunity Employer. #J-18808-Ljbffr MGS Mfg. Group