The Company
Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health.
We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.
OurQuality Assuranceteam are looking fora dynamic and skilled QMSSupervisorto support the start-up of our first European manufacturing site in Athenry.In this role, you willmaintainand sustainthe change control system and supportall document control activitiesin accordance withDexcom's processes, 21 CFR Part 820 and ISO13485.You willbe responsible forcreating andmaintainingrecords in the document control system, supervising document control department, compliance to FDA Regulation, standardscreationand 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 changeorders(CO's).
You will perform supervisory and administrative duties associated with document control & training.
Maintains and continuously improves document control system andSOP'sper FDA/ISOregulation standards requirements.
You will generate/present QA reports as needed and coordinate data to be presented in management review, Gemba reports, etc.
You willmonitorthestatus of in-process document changes to ensuretimelyrevisions.
You willassiststakeholderswith problem solving and offerpossible solutionsutilizingunderstanding of the job andapplyknowledge&skills to complete a wide range of tasks.
You will support Quality in both external and internal audits.
You willmaintainrecord integrity by the archiving and retrieval of quality recordsand other departmental records.
You will issuecontrolled documents.
You will prepare requests for reproduction of documents.
You willmaintainexternal standardsin accordance withstandard operating procedures.
You will oversee the maintenance of the filing system for Quality Record master drawings, CO's, Specifications, SOP's, etc., asrequired.
You willbe responsible forChange Order Board Administration. ReviewsCO'sfor accuracy,Monitorand follow-up on the status of required action.
You will assume and performother duties as assigned.
What makes you successful:
Typically requires aBachelor'sdegree 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 andChangeorder process.
You have an aptitude for detail, accuracy and excellent organization skills, knowledge of PC based programs such as: Microsoft Word, MRP system,Exceland 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.
Whatyou'llget:
A front row seat tolife changingCGM technology.Learn about our brave #dexcomwarriors community.
Afull andcomprehensive benefitsprogram.
Growth opportunities on a global scale.
Access tocareer development through in-house learning programs and/orqualifiedtuition reimbursement.
Anexcitingandinnovative,industry-leading organizationcommitted to our employees,customers, and the communities we serve.
Travel Required:
5-10%
To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicitedresumes/applications.