Founded in 1999, Dexcom, Inc. provides continuous glucose monitoring technology to help patients and their clinicians better manage diabetes. Since our inception, we have focused on better outcomes for patients, caregivers, and clinicians by delivering solutions for people with diabetes – while empowering our community to take control of diabetes.
- Support the effective control of nonconforming materials awaiting review, disposition determination and final disposition.
- Responsible for processing NCMRs, CAPA’s, Deviations, Effectiveness Checks and Change Control.
- Support sustaining efforts as they relate to manufacturing including continuous improvement opportunities for overall effective process control and monitoring (i.e., manufacturing components, subassemblies, and final products).
- Actively participates as a core team member of the sustaining Quality Assurance Engineering team, and commercial production team.
- Responsible for reviewing, authoring, and revising appropriate technical documentation including process instructions, standard operating procedures, protocols, reports, etc.
- STEM degree from accredited College/University.
- Able to organize and prioritize assignments providing direction to and participation in assigned functional teams.
- Proven ability to work hands-on in a fast-paced environment with competing priorities.
- Ability to deal with ambiguity/uncertainty and a willingness to try new/challenging things.
- Awareness to assist fellow engineers, operators, and technicians to complete their activities when opportunities arise.
- Excellent communication (written and verbal) and personal interaction skills.
Qualification & Experience:
- Experience in high volume manufacturing.
- Experience supporting sustaining operations in a quality role
- Knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization
- (ISO 13485 Quality management systems).
- Medical Device experience preferred.
Vacancy Type: Full Time
Job Location: San Diego, CA, US
Application Deadline: N/A