Manages the development and implementation of the organization’s quality policies and programs. Manages and mentors Quality Assurance staff. Assures systems are in compliance with ISO and FDA quality system regulations.
- Compiles statistical data and writes narrative reports summarizing quality findings.
- Manages Quality Assurance Team (Quality Assurance, Quality Control, QA Engineering). Defines priorities and delegates responsibilities.
- Manages and coordinates inspection, sampling, testing, and/or packaging of supplies/components and finished products.
- Coordinates, manages and tracks the QA team’s efforts, ensuring milestones are met within defined budgets and schedules.
- Applies risk management, equipment and process validation, sample size, and external standards review and implementation activities
- Manages, leads, improves, and maintains quality methodologies, processes, and procedures.
- Utilizes quality feedback data from customers and consumers to drive continual improvement activities needed to achieve department strategic goals.
- Establishes and implements quality specifications, standards and programs for supplies/components, finished products and/or the packaging thereof.
- Documents and reports quality findings to senior and executive management, project/program managers, development team. Follow-up on ongoing issues. Provides coaching and guidance on format, content and quality of project plans, requirements, design, and test cases.
- Document control, Nonconforming materials, Process controls, Receiving inspection, Training.
- Develops and monitors key metrics to assess the quality of products, supplies, inspection and testing systems.
- Assists research and development, engineering, etc., in formulating new products or in establishing standards for these products prior to initial production.
- Oversees personnel engaged in quality control/assurance.
- Reviews data on product defects, product response plans and product dispositions; recommends and implements improvements.
- 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,
- Develops master plan timetable for quality initiatives.
- 5 years of related experience and/or training; or equivalent combination of education and experience.
- Bachelor’s degree from four-year college or university preferred.
Vacancy Type: Full Time
Job Location: Mesa, AZ, US
Application Deadline: N/A