Document Control Specialist 3 - Evening Shift

Dexcom; Athenry; On-site; EUR 41,000 - 53,000; Full time

Benefits offered by this job

Comprehensive benefits

Career development

Global opportunities

Job summary

Dexcom Ireland is seeking a Document Control Specialist 3 to sustain the change control system and support all document control activities in line with 21 CFR Part 820 and ISO-13485. You will manage change orders, assist software training, and ensure timely document revisions while interacting with internal and external customers.

The role requires 4–6 years of related experience, a NFQ level 6 diploma or equivalent, and proficiency with Microsoft Office and electronic documentation systems.

Qualifications

• Minimum 4–6 years of related experience.
• NFQ Level 6 diploma or equivalent.

Responsibilities

• Manage the change control system and release change orders.
• Support document control audits and ISO 13485 compliance.
• Scan, archive and retrieve quality documents and records.
• Issue controlled and uncontrolled documents and maintain service records.
• Generate QA reports and support software training.

Skills

Microsoft Office

Electronic document systems

Critical thinking

Education

NFQ level 6 diploma

Tools

MS Office

Job description

The CompanyDexcom 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.Are you looking to leverage your experience to be part of something big and help people take control of their health? Do you enjoy building and managing relationships to better understand the needs of the business, and then creating and implementing solutions to meet those needs? Do you want to be part of a high-performing team dedicated to doing the right thing? If so, then we have an opening for you!As a Document Control Specialist 3, you will be responsible for sustaining the change control system and supporting all Document Control activities in accordance with Dexcom’s processes, 21 CFR Part 820 and ISO-13485. Competent with Microsoft office is a must for this position. Proficient in generating reports in order to support other Quality Assurance systems. The ability to use critical thinking and resolve issues is required. A highly driven, detailed oriented person is essential for this position. Knowledge of electronic documentation systems is required.This role is on a fixed evening shift patternMonday - Friday3:30 PM - 12 MidnightShift allowance 20%Where you come inYou will manage the change control system. Review, route and release change orders.You will assist in change control system software training and other training as required.You will ensure projects are completed accurately and on time.You will interact with internal and external customers.You will support Quality in both external and internal audits.You will monitor the status of in-process document changes to ensure timely revisions.You will assist customers with problem solving and offer possible solutions utilizing understanding of the job and applies knowledge and skills to complete a wide range of tasks.You will scan, archive and retrieve quality documents and records.You will issue controlled and uncontrolled documents.You will maintain service records of all departments.You will prepare requests for reproduction of documents.You will maintain external standards in accordance with standard operating procedures.You will support the development of documentation and configuration control procedures.You will support the testing and improvement of the change control software and other supporting software.You will generate Quality Assurance reports as needed.What makes you successfulProficient with Microsoft Office SuiteAbility to create reports in support of other Quality Assurance systems.Ability to use critical thinking and resolve issues.Knowledge of electronic documentation systems.Good understanding of Document Control requirements and processes as outlined in ISO 13485 and 20 CFR part820.Must have the ability to apply acquired knowledge of GDP and GMP to daily tasks.Able to support rotating shiftWhat 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.Experience and EducationTypically requires a minimum of 4-6 years of related experience and a NFQ level 6 diploma or equivalent.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 unsolicited resumes/applications.AI in Hiring Notice: We may use AI supported tools to help make our hiring process more efficient, consistent, and accessible for candidates around the world. All hiring decisions are made by people.At Dexcom, we are committed to providing a fair and inclusive recruitment process, and welcome candidates of all genders and gender identities to apply. If any wording in this description appears unintentionally gendered or exclusionary, please be assured this is not intentional.Should a reasonable accommodation be necessary to aid a disability, requests should be sent to Dexcom Talent Acquisition at [e-mail] .The annualised base salary for this position is from €41,055.00 to €53,130.00 gross. Final offer will depend on your qualifications, competencies, and professional experience.#DexcomIreland