QA Engineer 2

Dexcom; San Diego (CA); Remote; USD 68,000 - 114,000; Full time

Job summary

An established industry player is seeking a Quality Assurance Engineer 2 to enhance its quality systems and ensure compliance with regulations. This role involves collaborating with various teams to administer quality policies, manage risks, and support product development in a fast-paced environment. The ideal candidate will have a strong background in quality assurance, excellent communication skills, and the ability to thrive in a dynamic setting. Join a forward-thinking company dedicated to transforming diabetes care and making a positive impact on patients' lives.

Qualifications

• Minimum 2 years of experience in a quality role within regulated industries.
• Bachelor's degree required; advanced degree can waive experience.

Responsibilities

• Oversee application of quality system for various projects.
• Design and apply company policies for quality compliance.
• Participate in health hazard assessments for product issues.

Skills

Quality Assurance

Technical Writing

Regulatory Compliance

Risk Management

Communication Skills

Team Collaboration

Education

Bachelor's degree in a technical discipline

Master's degree in a related field

Tools

Microsoft Office

Database Applications (e.g. Excel)

Job description

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.

Meet the team:

Dexcom’s Software Design Quality Assurance Team is responsible for various aspects of Quality Engineering, including administration of specific aspects of the quality system. The Partnerships Team, within the Software QA Team, is also responsible for interfacing with Quality counterparts at other companies, for Dexcom’s various technical and program integrations. As a Quality Assurance Engineer 2, your job tasks require collaborating with multiple internal Dexcom functions (Quality Assurance, Research & Development, Software Development, Operations, Engineering, Regulatory Affairs, Clinical Affairs, Human Factors, Product Management, Legal, Finance, Customer Operations, Technical Support, and senior management) in addition to external functions of Dexcom partnerships. To succeed in this role, you must be systematic, highly organized, articulate, and able to work in a team environment. A positive attitude is important as Dexcom is a fast-paced atmosphere with constantly shifting priorities.

Where you come in:

1. You will administer and oversee application of specific aspects of the quality system for various projects and products across the business.
2. You will design and apply company policies and procedures that help Dexcom achieve its quality policy and compliance with domestic and international regulations. Some examples include Software and Test Method Validation, Auditing, CAPA, Customer complaint processing, Document control, Nonconforming materials, and Training.
3. As a member of the Partnerships Team, your activities may include co-development of partner Quality Agreements, risk management of interoperable systems, assessment of internal change impact to existing partnerships, and notification of change.
4. As a member of the Design Team, your activities may include assisting with defining design inputs, designing components and processes, and verifying that design outputs satisfy design inputs, all while guiding R&D teams through a risk-based approach to design.
5. You will participate in health hazard assessments for product field issues.
6. You will apply proficient computer skills in the use of Microsoft Office and database applications (e.g. Excel) and associated analysis of field data.

You are not expected to design or execute software testing in this role. This is not a Software Tester role.

What makes you successful:

1. You’ll need a minimum 2 years of related experience with a Bachelor’s degree (advanced degree can waive minimum experience); medical device or other regulated industry preferred.
2. Your ability to work in a hands-on, fast-paced environment.
3. Your proficiency at written and verbal communication skills, including experience with technical writing.
4. Your experience supporting product development and/or sustaining operations activities in a quality role.
5. You have a basic understanding of mobile device operating system software/hardware (applications, internet connection, Bluetooth communication).
6. An ASQ Certification (e.g. Certified Quality Engineer or Certified Software Quality Engineer).

Travel Required:

15 – 25%

Exempt Salary Details:

The annual base salary range for this role is $68,200 to $113,600. Final compensation package will ultimately depend on factors including relevant experience, skillset, knowledge, business needs and market demand.

Flex Workplace:

Your primary location will be a home office. You will not have an assigned workstation and will work with your manager to determine office visit needs.

Experience and Education

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