Dexcom, Inc. empowers people to take control of diabetes through innovative continuous glucose monitoring (CGM) systems. Headquartered in San Diego, California, Dexcom has emerged as a leader of diabetes care technology. By listening to the needs of users, caregivers, and providers, Dexcom simplifies and improves diabetes management around the world.
Summary:
This position is responsible for maintaining and sustaining the change control system and supporting all Document Control activities in accordance with Dexcom's processes, 21 CFR Part 820 and ISO-13485. Intermediate to proficient in Microsoft office is a must for this position. Intermediate in generating reports 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. Must have the ability to apply acquired knowledge of GDP and GMP to daily tasks.
Functional Description: Support Individual Contributor
Implements and maintains an Engineering Change Notice System and associated Training System. These changes will include product improvements, repairs, and new product development. Coordinates the interaction between engineering, manufacturing, field operations, and marketing to ensure appropriate changes are documented.
Essential Duties and Responsibilities:
Manage the change control system (Agile); Review, route, assess training impact and release change orders.
Support the establishment and improvement of quality systems and facilitate continuous quality improvements in Dexcom's continuous efforts to improve the Quality System.
Generate/Present QA reports as needed and coordinate data to be presented in Gemba reports.
Assist in Agile software/Quality training and other training as required.
Monitoring status of in-process document changes to ensure timely revisions.
Able to positively interact with internal and external customers.
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.
Support Quality in both external and internal audits.
Maintain record integrity through archiving and retrieval of quality and departmental records.
Issues controlled and uncontrolled documents.
Prepare requests for reproduction of documents.
Maintain external standards in accordance with standard operating procedures.
Independently work on moderately difficult assignments with minimal guidance but have the ability to organize results to be presented and understood by Management.
Support the testing and improvement of the change control software and other supporting software.
Support manufacturing operations by creating, processing, distributing and controlling revisions of all manufacturing documentation.
Support the development of documentation and configuration control procedures.
This position assumes and performs other duties as assigned.
Required Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Minimum of 3+ years recent experience in Quality Systems is required
Knowledge of all aspects of documentation control and Change order process
Aptitude for detail, accuracy and excellent organization skills, knowledge of PC based programs such as: Microsoft Word, MRP system, Excel and data input
Ability to create and present reports in support of Quality Assurance systems
A high capacity to use critical thinking and resolve issues are required.
Strong understanding of Document Control requirements and processes as outlined in ISO 13485 and 21 CFR part 820.
Ability to apply and educate others of acquired knowledge of GDP and GMP to daily tasks.
Experience and Education Requirements:
Typically requires a minimum of 2-4 years of related experience and a High School diploma/certificate or equivalent.
Travel Required:
Up to 25%
Functional/Business Knowledge:
Moderate understanding of general job aspects and some understanding of the detailed aspects of the job.
Applies acquired job and company knowledge of policies and procedures to complete semi-routine tasks.
Scope:
Work at this level requires following standardized methods and under immediate supervision on assignments that are semi-routine in nature.
Follows pre-established guidelines and procedures with minimal choice as to method of performance of the work.
Has contact with employees at other levels within the company. Information exchanged is generally non-complex.
Judgement:
Normally follows established procedures on routine work, requires instructions only on new assignments.
Works under close supervision.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Talent Acquisition at talentacquisition@dexcom.com.
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.
