Summary:Developing professional expertise, applies company policies and procedures to resolve a variety of issues.
Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
Exercises judgment within defined procedures and practices to determine appropriate action.
Builds productive internal/external working relationships.Essential Duties and Responsibilities (performance expectations vary by level):Design, 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).Involve in review, implements and maintains quality assurance protocols and methods for processing materials into partially finished or finished products.Involve in designs methods and procedures for inspecting, testing and evaluating the precision and accuracy of production processes, production equipment and finished products.May support the supervision and administration of specific aspects of the quality system.Support the development of systems and performs quality functions that help Dexcom achieve its quality policy and compliance with domestic and international regulations.
Some examples include Auditing, Calibrations, CAPA, Customer complaint processing, Document control, Nonconforming materials, Process controls, Receiving inspection, Training.Support the internal audits to ensure systems comply with requirements and are effective.Support risk management, validation, sample size, and external standards review and implementation activities.Employs techniques like six sigma, lean manufacturing to improve Dexcom operations.Improves systems and processes that improve product safety; increase product consistency and conformance to requirements; improve production efficiency; reduce operating and scrap costs.Coordinates the disposition of nonconforming materials with the Materials Review Board.Reads, writes, and understands specifications and inspection criteria to apply criteria using appropriate and properly configured inspection tools.
Reviews schematics and mechanical drawings.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.Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily per defined job level.
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.Experience and Education Requirements: Bachelor's degree and typically 0-2 years of related experience; or equivalent combination of education and experience.
Medical Device experience preferred.Language Skills:Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
Ability to write reports, business correspondence, and procedure manuals.
Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.Mathematical Skills:Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume.
Ability to apply concepts of basic algebra and geometry.Reasoning Ability:Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.