QA Engineering - QA Engineer 1 at Dexcom in San Diego, California

Job Description:

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 incumbent is responsible for performing all the duties of a Supplier Quality Engineer 1. Performs tasks with moderate oversight from the manager and/or designated senior level supplier QEs. Will assist senior quality engineers in the performance of their duties and will support, evaluate, revise, and implement specific aspects of the quality system, as assigned. The incumbent will be systematic, highly organized and articulate, and work well in a team environment. Job tasks require interfacing with external suppliers, internal manufacturing, engineering, regulatory, quality, materials, and operations personnel, and senior management. Will provide guidance and training to technical and administrative personnel, and incoming new hires, as assigned. A positive attitude is important while working in a fast-paced manufacturing 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).

Functional/Business Knowledge:

• Applies basic technical understanding with the knowledge to develop process and design experiments. Possesses theoretical knowledge, but is learning the industry and requirements of applied science. Understands organizational and functional processes and policies.

Essential Duties and Responsibilities

• Maintain the supplier quality management system according to written policies and procedures. Will provide input on compliance and continuous improvement of business processes.


• Provide quality guidance to other departments.


• Support senior QEs in conducting supplier audits, monitor supplier performance, provide information for supplier program metrics and periodic reports, and assist in administration of the supplier corrective action system.


• Ability to travel in the U.S. and internationally.


• Provides relevant supplier related input to the Supplier Review Committee (SRC).


• Assists senior level QE in maintaining the Supplier Audit Schedule and monitors compliance with this schedule, on an ongoing basis.


• May attend and support internal audits by regulatory and other outside agencies.


• Provides support in drafting supplier Quality Agreements, where needed, and supports any joint periodic supplier business reviews.


• Reviews and approves supplier documentation (protocols, reports, specifications, etc.), as defined in the Quality Agreement.


• May work as a member of the design team, as required. Some type of activities may include assisting with defining design inputs; designing components and processes; verifying that design outputs satisfy design inputs.


• Have knowledge of techniques like six sigma, lean manufacturing, sampling plans and statistics; utilizing these techniques as appropriate per Dexcom and/or industry recognized standards.


• Takes the initiative to suggest systems and process improvements that: increase product safety; increase product consistency and conformance to requirements; improve production efficiency and communication; reduce operating and scrap costs.


• Reads and understands specifications and inspection criteria.

• Reads schematics and mechanical drawings and provides input into revisions, as needed.


• Works and communicates effectively and professionally in a team environment with minimal supervision.

• Applies proficient computer skills in the use of Microsoft Office and database applications (such as Oracle and Agile).


• Has understanding of Design and Process Failure Mode Effect Analysis (DFMEA) and Process Failure Mode Effect Analysis (PFMEA).


• Possess a basic understanding of the Quality Systems Regulations 21CFR Part 820 and international quality systems and medical device standards including ISO 13485.


• Previous training and/or certification to perform quality audits is highly desired.


• Experience with supplier quality programs is highly desired.


• Assumes and performs other duties as assigned.

Supervisory Responsibilities

• This job does not have supervisory responsibilities.

Qualifications

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and/or Experience

• Bachelor's Degree in a scientific or related discipline is preferred. A minimum of two years' of relevant QA work experience in the medical device manufacturing or subcontracting industry. An equivalent combination of education and experience will be considered.

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.
  
  

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.

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.

View the OFCCP's Pay Transparency Non Discrimination Provision at this link.

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