QA Engineer 2

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

• 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).
• 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.
• Performs analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary.
• 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 assure compliance to in-house and/or external specifications and standards (i.e. GLP, GMP, ISO).
• May supervise and administer specific aspects of the quality system.
• Develops 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.
• Performs internal audits to ensure systems comply with requirements and are effective.
• Participates as member of the design team. Activities may include assisting with defining design inputs; designing components and processes; verifying that design outputs satisfy design inputs.
• Leads risk management, validation, sample size, and external standards review and implementation activities.
• Employs techniques like six sigma, lean manufacturing and Total Quality Management 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 minimum 2 years of related experience; or an advanced degree without experience; or equivalent combination of education and experience. Medical Device experience preferred.