Job description
Meet the team:
As a Sr. Quality Assurance Engineer (QA Engineer - Data Analytics) your role will be responsible for defining requirements, developing, validating and deploying Quality Assurance data and information dashboards with focus on Manufacturing Controls, Quality Management Systems and New Product Development. This position will interface with different cross functional groups (Data Analytics, Customer Advocacy, Quality Engineering, Software Engineering, Software Test, Regulatory Affairs, and others). This role provides technical support and guidance to all of Sustaining Quality Engineering and Quality Control teams to ensure they have the necessary information to make quality decision on a daily basis, facilitate compliance to Dexcom’s Quality Management System and international regulation standards (e.g. 21 CFR Part 11, 801, 803, 820; ISO 13485, ISO 14971).
Where you come in:
- Mines, analyze and compile system wide database data to support quality management decisions.
- Designs, develops, validates, and deploy Quality Assurance information and data support dashboards, for all areas of Operations Quality Assurance in San Diego.
- Designs, develops, validates, and deploys Quality Assurance Metric Dashboards for all areas of Operations Quality Assurance in San Diego.
- Designs and performs Equipment, Process, Software and Test Method Validations.
- 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.
- 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.
- Assumes and performs other duties as assigned.
- Applies proficient computer skills in the use of Microsoft Office and database applications (e.g. SQL, R, and MiniTab, Jump).
- Expertise in the use of data visualization software packages like Tableau, Power BI, OSiPi
- Proficiency in data mining and advance analytics to provide insight to Quality Engineering, Quality Compliance and Quality Control Groups
- Experience with statistical analysis and statistical analysis software packages like Minitab and Jump
- Experience with Oracle, Camstar, EtQ Reliance, Google Big Query, Korber, SQL Servers
- Database programing software expertise
- A positive attitude is important while working in a fast-paced environment and dealing with shifting priorities.
- Certified Quality Engineer, Certified Software Quality Engineer a plus.
- 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 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.
Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
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 .
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 .
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.
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