Document Control Specialist 3 - Evening Shift

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

Benefits offered by this job

Comprehensive benefits

Career development

Global growth opportunities

Tuition reimbursement

Dexcom community

Job summary

Dexcom Ireland is seeking a Quality Assurance professional to manage the change control system and ensure accurate document control across GMP/GDP processes. The role will review change orders, assist in training, and support audits in a fast-paced CGM environment.

The position requires 4–6 years of related experience and an NFQ level 6 diploma. The annual base salary ranges from €41,055 to €53,130, with an evening shift allowance of 20%. Final offer depends on qualifications and experience.

Qualifications

• Proficient with Microsoft Office Suite.
• Ability to create reports in support of QA systems.
• Able to apply critical thinking to resolve issues.
• Knowledge of electronic documentation systems.
• Good understanding of Document Control per ISO 13485 and 20 CFR part 820.
• Ability to apply GDP and GMP knowledge to daily tasks.

Responsibilities

• Manage the change control system.
• Review, route and release change orders.
• Assist in change control software training and other training as required.
• Ensure projects are completed accurately and on time.
• Interact with internal and external customers.
• Support Quality in audits (internal and external).
• Monitor in-process document changes for timely revisions.
• Assist customers with problem solving using job knowledge.
• Scan, archive and retrieve quality documents and records.
• Issue controlled and uncontrolled documents.
• Maintain service records of all departments.
• Prepare requests for reproduction of documents.
• Maintain external standards per SOPs.
• Support development of documentation and configuration control procedures.
• Support testing and improvement of change control software and other supporting software.
• Generate QA reports as needed.

Skills

Microsoft Office

Report writing

Critical thinking

Electronic documentation systems

ISO 13485 knowledge

GDP & GMP knowledge

Shift work

Education

NFQ level 6 diploma

Job description

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. 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!

Where you come in

• You 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.

This role is on a fixed evening shift pattern Monday - Friday 3:30 PM - 12 Midnight Shift allowance 20%

What makes you successful

• Proficient with Microsoft Office Suite
• Ability 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 shift

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.

Experience and Education

Typically requires a minimum of 4-6 years of related experience and a NFQ level 6 diploma or equivalent.

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 Since 1999, Dexcom has simplified and revolutionized diabetes management, positively impacting millions worldwide. At Dexcom, we're more than just a medical device company; we're a collective of visionary thinkers, trailblazers, and problem solvers. Our mission transcends the ordinary. We aim to revolutionize healthcare, one groundbreaking technology at a time.