Sr QA Engineer

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 full-year 2022 revenues of $2.9B, a growth of 18% over 2021. Headquartered in San Diego, California, with additional offices in the Americas, Europe, and Asia Pacific, the company employs over 8,000 people worldwide.

Description:

As a Sr QA Engineer your role will be responsible for coordinating Corrective and Preventive Actions (CAPA), Non-Conforming Events (NCE), and Health Hazard Assessments (HHA), support Internal and External Audits, defining requirements and aiding in the development of analytic dashboards, 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 (Operations Data Analytics, Customer Advocacy, Quality Engineering, Software Engineering, Software Test, Regulatory Affairs, and others). The Sr. Quality Engineer role provides Quality Assurance Engineering and Compliance expertise, and technical support to Sustaining Quality Engineering and Quality Control teams to ensure they have the necessary information to make quality decisions, 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).

Scope:

• Coordinates and ensures compliance to CAPA, NCE and HHA systems. Provide guidance as necessary to ensure appropriate depth of investigation and corrective and/or preventive actions. Assess effectiveness of corrective and preventive actions. Prepare QA Review Board meetings agenda and minutes.
• Aid in the design, development, validation, and deployment of Quality Assurance Metric Dashboards for all areas of Operations Quality Assurance in San Diego.
• QA Continuous Improvement Projects
• 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.
• 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.
• Assumes and performs other duties as assigned.

Requirement:

• Direct experience with Quality Management Systems, Nonconforming Material, Nonconforming Events, CAPA, and Internal Auditing.
• Good understanding of QMS as applied to medical devices.
• Collaborative, able to work effectively with diverse functional groups.
• Demonstrates good judgment in selecting methods and techniques for problem solving and obtaining solutions.
• Can work well alone, normally receives little instruction on day-to-day work, general instructions on new assignments.
• A positive attitude is important while working in a fast-paced environment and dealing with shifting priorities.
• Experience with Oracle, Camstar, EtQ Reliance, 1Factory, Korber, SQL Servers
• Experience with statistical analysis and statistical analysis software packages like Minitab and Jump
• Certified Quality Engineer, Certified Quality Auditor a plus.

Workplace Type:

• The Workplace Type for this role is Assigned Desk. Based on the nature of your role you will have an assigned desk or office located at a Dexcom site and should plan to be onsite approximately 4-5 days per week.

Work schedule:

• First shift: Monday through Friday between 8:00AM - 5:00PM- Pacific time

Travel Required:

• 0 to 5%

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 [email protected].

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 [email protected].

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.

Salary:

$82,900.00 - $138,100.00