Flex your innovative engineering skills in this role! Work with Manufacturing Automated Equipment for world class quality CGM products. Your top skills in quality processes and improvement will be utilized with regards to Equipment, Process, Software and Test Method Validation, Auditing, Calibrations, CAPA, Customer complaint processing, Document control, Nonconforming materials, Process controls, and more.
- Designs and applies company policies and procedures that help Dexcom achieve its quality policy and compliance with domestic and international regulations. Some examples include
- Equipment, Process, Software and Test Method Validation, Auditing, Calibrations, CAPA, Customer complaint processing, Document control, Nonconforming materials, Process controls,
- Receiving inspection, Training.
- Effectively communicates with broad Dexcom team and upper level management on project progress and challenges.
- Improves systems and processes that improve product safety; increase product consistency and conformance to requirements; improve production efficiency; reduce operating and scrap costs.
- Reads, writes, and understands specifications and inspection criteria to apply criteria using appropriate and properly configured inspection tools.
- Sustaining engineering support for legacy and new products.
- Applies risk management, validation, sample size, and external standards review and implementation activities.
- Applies techniques like six sigma, lean manufacturing and Total Quality Management to improve Dexcom operations.
- Develop and support verification activities for Equipment, Process, Software and Test Method Validations.
- Actively p articipate as a core team member for automated equipment development teams. Duties include providing technical guidance, defining equipment requirements, participate in concept and design reviews, defining equipment/process failure mode effects and analysis (FMEA), ensuring equipment meet product/process specifications, buyoff equipment from vendors.
- Leads or participates in internal audits, supplier audits to ensure systems comply with requirements and are effective.
- The position may be responsible for various aspects of Quality Engineering and will require interfacing with all functions (Operations, Quality Assurance, Engineering, R&D, Regulatory
- Affairs, Marketing, Legal, Customer Operations, upper levels of management, vendors, and contract manufacturers).
- Applies proficient computer skills in the use of Microsoft Office and database applications (e.g. Excel and MiniTab).
- Assists with investigation and disposition of nonconforming materials with the Materials Review Board.
- Review schematics and mechanical drawings.
- Assumes and performs other duties as assigned.
Qualification & Experience:
- Able to organize and prioritize assignments providing direction to and participation in assigned functional teams.
- At least 2 years of hands-on experience with high volume manufacturing and equipment development for assembly and automation systems.
- Technical writing skills as applied to manufacturing documentation and process development – Experienced in the creation and revision of technical documentation.
- Excellent communication (written and verbal) and personal interaction skills.
Vacancy Type: Full Time
Job Location: San Diego, CA, US
Application Deadline: N/A