QMS Supervisor

Our Quality Assurance team are looking for a dynamic and skilled QMS Supervisor to support the start-up of our first European manufacturing site in Athenry. In this role, you will maintain and sustain the change control system and support all document control activities in accordance with Dexcom’s processes, 21 CFR Part 820 and ISO13485. You will be responsible for creating and maintaining records in the document control system, supervising document control department, compliance to FDA Regulation, standards creation and organization, change order system management and document control room security. You will also plan, process and coordinate preparation of documentation projects such as engineering control, documentation processing requirements for each phase of the design and manufacturing process.  

Where you come in:  

• You will manage the change control system; review, route, assess impact and release change orders (CO’s). 

• You will perform supervisory and administrative duties associated with document control & training. 

• Maintains and continuously improves document control system and SOP’s per FDA/ISO regulation standards requirements. 

• You will generate/present QA reports as needed and coordinate data to be presented in management review, Gemba reports, etc. 

• You will monitor the status of in-process document changes to ensure timely revisions. 

• You will assist stakeholders with problem solving and offer possible solutions utilizing understanding of the job and apply knowledge & skills to complete a wide range of tasks. 

• You will support Quality in both external and internal audits. 

• You will maintain record integrity by the archiving and retrieval of quality records and other departmental records. 

• You will issue controlled documents. 

• You will prepare requests for reproduction of documents. 

• You will maintain external standards in accordance with standard operating procedures. 

• You will oversee the maintenance of the filing system for Quality Record master drawings, CO’s, Specifications, SOP’s, etc., as required. 

• You will be responsible for Change Order Board Administration. Reviews CO’s for accuracy, Monitor and follow-up on the status of required action. 

• You will assume and perform other duties as assigned. 

What makes you successful:  

• Typically requires a Bachelor’s degree with 5-8 years of industry experience. Informal management/ team lead experience. 

• You have 4 - 6 years recent experience in Quality Systems 

• You have thorough knowledge of all aspects of documentation control and Change order process. 

• You have an aptitude for detail, accuracy and excellent organization skills, knowledge of PC based programs such as: Microsoft Word, MRP system, Excel and data input. You have a solid understanding of international and domestic medical device GMPs/ Quality System Requirements. 

• You have the ability to identify, and resolve problems, and handle multiple assignments. 

What you’ll get:  

• A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community. 

• A full and comprehensive benefits program. 

• Growth opportunities on a global scale. 

• Access to career development through in-house learning programs and/or qualified tuition reimbursement. 

• An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.  

Travel Required:  

• 5-10%