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Sr QA Engineer

Company: DexCom, Inc.
Location: Mesa
Posted on: January 17, 2023

Job Description:

About Dexcom

Founded in 1999, Dexcom, Inc. (NASDAQ: DXCM), develops and markets Continuous Glucose Monitoring (CGM) systems for ambulatory use by people with diabetes and by healthcare providers for the treatment of people with diabetes. The company is the leader in transforming diabetes care and management by providing CGM technology to help patients and healthcare professionals better manage diabetes. Since the company's inception, Dexcom has focused on better outcomes for patients, caregivers, and clinicians by delivering solutions that are best in class - while empowering the community to take control of diabetes. Dexcom reported expected full-year 2021 revenues of $2.48B, a growth of 27% over 2020. Headquartered in San Diego, California, with additional offices in the Americas, Europe, and Asia Pacific, the company employs over 6,000 people worldwide.

Essential Duties and Responsibilities:

* May administer specific aspects of the quality system.
* Designs and applies company policies and procedures that help Dexcom achieve its quality policy and compliance with domestic and international regulations. Some examples include Equipment, Process, Software and Test Method Validation, Auditing, Calibrations, CAPA, Customer complaint processing, Document control, Nonconforming materials, Process controls, Receiving inspection, Training.
* Participates in internal audits, supplier audits to ensure systems comply with requirements and are effective.
* Designs and performs Equipment, Process, Software and Test Method Validations.
* Participates as member of the design team. Activities may include assisting with defining design inputs; designing components and processes; verifying that design outputs satisfy design inputs.
* Applies risk management, validation, sample size, and external standards review and implementation activities.
* Applies techniques like six sigma, lean manufacturing and Total Quality Management to improve Dexcom operations.
* Applies systems and processes that improve product safety; increase product consistency and conformance to requirements; improve production efficiency; reduce operating and scrap costs.
* Coordinates the disposition of nonconforming materials with the Materials Review Board.
* Reads, writes, and understands specifications and inspection criteria to apply criteria using appropriate and properly configured inspection tools.
* Reviews and creates schematics and mechanical drawings.
* Applies proficient computer skills in the use of Microsoft Office and database applications (e.g. Excel and MiniTab).
* Assumes and performs other duties as assigned.

Required Qualifications:

* Minimum 5 years of related experience with Bachelor's degree (advanced degree can waive minimum experience)
* Ability to work in a hands-on, fast-paced environment.
* Demonstrated written and verbal communication skills

Preferred Qualifications:

* Direct involvement in medical device or regulated industry
* Experience supporting sustaining operations in quality role
* Enter qualifications preferred, such as certifications, industry experience, etc.
* ASQ Certification (e.g. Certified Quality Engineer)

Exempt Salary Details:

The annual base salary range for this role is $82,900.00 to $138,100.00. Final compensation package will ultimately depend on factors including relevant experience, skillset, knowledge, business needs and market demand.

Functional Description

Designs, implements and maintains quality assurance protocols and methods for processing materials into partially finished or finished products. Responsible for planning, implementing and managing compliance of manufacturing and production processes with internal and external safety, quality and regulatory standards requirements for worldwide distribution. Designs methods and procedures for inspecting, testing and evaluating the precision and accuracy of production processes, production equipment and finished products. Performs analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary. May assure compliance to in-house and/or external specifications and standards (i.e. GLP, GMP, ISO, Six Sigma).

Functional/Business Knowledge

* Possesses broad understanding of technical principles and theories. Ability to synthesize external data and research findings for application that may impact technical objectives.

Scope

* Demonstrates successes in technical proficiency and independent thought. Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.

Judgement

* Exercises good judgment in selecting methods and techniques for obtaining solutions.
* Normally receives little instruction on day-to-day work, general instructions on new assignments.

Management

* N/A

Field Sales

* N/A

Experience and Education

* Typically requires a Bachelors degree in a technical discipline, and a minimum of 5-8 years related experience or Masters degree and 2-5 years equivalent industry experience or a PhD and 0-2 years experience.

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 Dexcom Talent Acquisition at talentacquisition@dexcom.com.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom's AAP may be viewed upon request by contacting Talent Acquisition at talentacquisition@dexcom.com.

View the OFCCP's Pay Transparency Non Discrimination Provision at this link.

UnitedHealthcare creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided: https://transparency-in-coverage.uhc.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.

Keywords: DexCom, Inc., Mesa , Sr QA Engineer, Other , Mesa, Arizona

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