Sr QA Engineer
Dexcom, Inc

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 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 7,000 people worldwide.

FUNCTIONAL DESCRIPTION: Technical Individual Contributor

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. Provide guidance on EU MDR as well as 21 CFR 820 & 21 CFR Part 11. Lead and support sustaining efforts including continuous improvement opportunities for overall manufacturing processes. Performs analysis of reports and production, storage, and distribution 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). Needs to be experienced with and have the ability to provide effective risk management and/or risk-based quality guidance for material controls, environmental monitoring and control systems, validation, sample size, and external standards review and implementation activities.

Summary:

A Senior Quality Engineer provides technical support for sustaining efforts, projects, functions, and strategic objectives of Sustaining Quality. The position will be responsible for various aspects of Quality Engineering, and will require interfacing with all functions (Information Technology, Quality Assurance, Operations, Engineering, R&D, Regulatory Affairs, Marketing, Legal, Customer Operations, upper levels of management, vendors, and contract manufacturers). Personnel in this role must be systematic, highly organized, and articulate within a cross-functional team environment. A positive attitude is important while working in a fast-paced environment and dealing with shifting priorities.

Essential Duties and Responsibilities:

• Actively participates as a core team member of the sustaining Quality Assurance Engineering team.
• Strong understanding of, and ability to provide guidance on EU MDR as well as 21 CFR 820 & 21 CFR Part 11.
• Designs and applies company policies and procedures that help Dexcom achieve its quality policy and compliance with domestic and international regulations.
• Lead and support sustaining efforts including continuous improvement opportunities for overall manufacturing.
• Reads, writes, and understands specifications and inspection criteria to apply criteria using appropriate and properly configured inspection tools.
• Responsible for effective control of nonconforming materials awaiting review, disposition determination and final disposition.
• Responsible for reviewing, authoring, and revising appropriate technical documentation including process instructions, standard operating procedures, protocols, reports, etc.
• Responsible for processing NCMRs, CAPA's, Deviations, Effectiveness Checks and Change Controls.
• Assesses impact of change control to qualified systems to ensure a state of compliance is maintained.
• Conducts investigations and performs root cause analysis for nonconformances and issues that arise during qualification activities.
• Effectively communicates with broad Dexcom team and upper level management on status of tasks, project progress and challenges.
• Experience with and ability to apply effective risk management and/or risk-based quality guidance for validation, sample size, and external standards review and implementation activities.
• Provides technical guidance with respect to equipment, software, product, and process requirements including defining and identifying failure mode effects and analysis (FMEA)
• Applies techniques like six sigma, lean manufacturing, and Total Quality Management to improve Dexcom operations.
• Improves systems and processes that improve product safety; increase product consistency and conformance to requirements; improve production efficiency; reduce operating and scrap costs.
• 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:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily per defined job level. The requirements listed above and below are representative of the knowledge, skill, and/or ability required.

• STEM degree from accredited College/University.
• Minimum of 5-8 years related experience, or Master's degree and 2-5 years equivalent industry experience or PhD and 0-2 years' experience.
• Medical Device experience preferred.
• Knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO 13485 Quality management systems)
• Excellent communication (written and verbal) and personal interaction skills. Able to organize and prioritize assignments providing direction to and participation in assigned functional teams.
• Technical writing skills as applied to manufacturing documentation and process development - Experienced in the creation and revision of technical documentation.
• Ability to deal with ambiguity/uncertainty and a willingness to try new/challenging things.
• Proven ability to work hands-on in a fast-paced environment with competing priorities.
• Awareness to assist fellow engineers, operators, and technicians complete their activities when opportunities arises.
• Detailed oriented with strong time management skills.

Preferred Qualifications:

• Familiar with experimental design, data analysis, and interpretation of experiments; JMP experience preferred.
• Experience supporting sustaining operations in quality role.
• Knowledge of continuous integration and deployment.
• Use your knowledge and specialized skills to implement technical solutions and provide high quality support.
• Interact with management and staff to provide analytical and technical assistance for continuous improvement.
• Manage and lead technical projects.
• Identify root-causes of operational issues and process inefficiencies.

Travel Required:

• 15 - 24%

Exempt Salary Details:

• The annual base salary range for this role is $82,900 to $138,100. Final compensation package will ultimately depend on factors including relevant experience, skillset, knowledge, business needs and market demand.
  

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.

This job has expired.