Staff Quality Assurance Engineer - Design (Finance)

About Dexcom:

Dexcom, Inc. empowers people to take control of diabetes through innovative continuous glucose monitoring (CGM) systems. Headquartered in San Diego, California, Dexcom has emerged as a leader of diabetes care technology. By listening to the needs of users, caregivers, and providers, Dexcom simplifies and improves diabetes management around the world.

Summary:

The Staff Quality Engineer provides technical support for product improvement efforts, projects, and strategic objectives of R&D Quality Assurance , with concentration on failure and trending analysis, product improvements, and new product development defect prevention. The position will be responsible for various aspects of Quality Engineering, and will require interfacing with all functions (, Operations, Engineering, R&D, Regulatory Affairs, Marketing, Legal, Customer Operations, and vendors including 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.

Functional Description: Technical Individual Contributors

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).

Essential Duties and Responsibilities:

• Actively participates as a core team member of the R&D Quality Assurance Engineering team.
• Strong understanding of, and ability to provide guidance on EU MDR, 21 CFR 820, and other relevant regulations worldwide
• Designs and applies company policies and procedures that help Dexcom achieve its quality policy and compliance with domestic and international regulations.
• Lead and support R&D QA efforts including continuous improvement opportunities for products and processes
• Reads, writes, and understands material specifications and inspection criteria to apply criteria using appropriate and properly configured inspection tools.
• Responsible for reviewing, authoring, and revising appropriate technical documentation including design history file, standard operating procedures, protocols, reports, etc.
• May be responsible for owning CAPAs
• Assesses impact of change control to ensure no adverse impact to product performance and a state of compliance is maintained.
• Conducts investigations and performs root cause analysis for nonconformances and issues that arise during design and process development and post commercialization activities.
• Effectively communicates with broad Dexcom team and upper level management on plans, status of tasks, project progress and challenges.
• Expertise to analyze risk and apply effective risk management and/or risk-based quality guidance controlling risk, verifying risk controls, and maintaining risk management throughout the product lifecycle.
• 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, or Total Quality Management to improve Dexcom operations.
• 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.

• 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.
• Ability to work with many different software development teams to develop, test, deploy and report on product performance, quality, security, and stability.
• 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.

Experience and Education Requirements:

• Typically requires a Bachelor's degree in a technical discipline, and a minimum of 8-12 years related experience or Master's degree and 5-7 years equivalent industry experience or a PhD and 2-4 years of experience.

Travel Required:

• Up to 25%

Functional/Business Knowledge:

• Possesses advanced knowledge of technical principles and theories. Recommends solutions in support of functional objectives tied to overall company objectives and strategies.

Scope:

• Demonstrates significant technical expertise, collaboration with others and independent thought. Anticipates potential complex problems requiring an in‐depth evaluation. Demonstrates strategic thinking and commercial/industry understanding in functional projects.

Judgement:

• Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.
• Determines methods and procedures on new assignments and may coordinate activities of other colleagues.

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An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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 Talent Acquisition at talentacquisition@dexcom.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.