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 pattern
Monday - Friday
3:30 PM - 12 Midnight
Shift allowance 20%
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.
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.
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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 talentacquisition@dexcom.com.
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.
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