Best Practices, Biotech and Pharmaceutical, Corporate Policies, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Customer Relations, Detail Oriented, Document Control, Document Management, Establish Priorities, External Audit, Healthcare Providers, ISO (International Organization for Standardization), ISO 14001, ISO 9001, Internal Audit, International Health, Maintain Compliance, Manufacturing, Manufacturing Analysis, Manufacturing/Industrial Processes, Medical Equipment, Multitasking, Onboarding, Presentation/Verbal Skills, Process Analysis, Project/Program Management, Quality Control, Quality Management, Records Management, Regulations, Regulatory Compliance, Software Administration, Spanish Language, Systems Administration/Management
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 13485 (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 Instruction 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 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 analytics
- Analyze manufacturing quality processes such as batch release, CAPA, Hold Material and validation in order to recommend improvement
- Any other duties as assigned.
ABOUT MGS:
As 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.
Keyword: Quality Systems and Compliance Manager
Required Experience:
A qualified Quality Systems and Compliance Manager would fulfill these requirements:
- Completion of a bachelor’s degree in Pharmaceutical, Medical Device, or engineering discipline.
- Experience with Quality System Management, ideally ISO13485
- At least 5 years’ experience working within a Quality systems, project or day to day quality role within a regulated manufacturing environment
- Proficient in Microsoft Office Applications
- Professional verbal and written communication
- Excellent attention to detail and accuracy
- Ability to multi-task and prioritize
- Ability to read, write, comprehend, and communicate the Spanish language in a proficient manner is preferred.
MGS is an Equal Opportunity Employer.
Benefits:
We offer an excellent benefits package including medical, dental, vision, 401K, disability, life, FSA, vacation, and holidays.
From: MGS Mfg. Group, Inc