Meet the team:As a Staff QA Engineer your role will be responsible for defining requirements and development of analytic dashboards, validating, and deploying Quality Assurance data and information dashboards with focus on Manufacturing Controls, Quality Management Systems and New Product Development. This role is also responsible for executing and coordinating Site Management Reviews for the San Diego site and coordinating data transfer for Corporate Management Reviews. Also, this role leads and coordinates the Non-Conforming Events (NCE), support Internal and External Audits. This position will interface with different cross functional groups (Operations Data Analytics, Customer Advocacy, Quality Engineering, Software Engineering, Software Test, Regulatory Affairs, and others). The Staff Quality Engineer role provides Quality Assurance Engineering and Compliance expertise, and technical support to Sustaining Quality Engineering and Quality Control teams to ensure they have the necessary information to make quality decisions, facilitate compliance to Dexcom's Quality Management System and international regulation standards (e.g. 21 CFR Part 11, 801, 803, 820; ISO 13485, ISO 14971).
Where you come in: - Leads the design, development, validation, and deployment of Quality Assurance Metric Dashboards for all areas of Operations Quality Assurance in San Diego.
- Leads and coordinates the Non-Conforming Events (NCE) system.
- May administer specific aspects of the quality system.
- 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.
- Participates in internal and external audits to ensure systems comply with requirements and are effective.
- Participates as a member of design teams representing Quality Assurance. Activities may include assisting with defining design inputs; designing components and processes; verifying that design outputs satisfy design inputs.
- Apply risk management, validation, sample size, and external standards review and implementation activities.
- 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.
- QA Continuous Improvement Projects
- Assumes and performs other duties as assigned.
What makes you successful: - Direct experience with Quality Management Systems, Nonconforming Material, CAPA, HHA/HHE, Nonconforming Events, Internal and External Audits.
- Good understanding of QMS as applied to medical devices.
- Direct experience developing dashboards in Power BI, Tableau,
- Experience with Oracle, Camstar, IQVIA, 1Factory, EtQ Reliance, SQL Servers, Google Big Query.
- Experience with statistical analysis and statistical analysis software packages like Minitab and Jump
- Experience in FDA audits
- Collaborative, able to work effectively and lead diverse functional groups.
- Demonstrates good judgment in selecting methods and techniques for problem solving and obtaining solutions.
- Can work well alone, normally receives little instruction on day-to-day work, general instructions on new assignments.
- A positive attitude is important while working in a fast-paced environment and dealing with shifting priorities.
- Certified Quality Engineer, Certified Quality Auditor a plus.
What you'll get: - A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community.
- A full and comprehensive benefits program.
- Growth opportunities on a global scale.
- Access to career development through in-house learning programs and/or qualified tuition reimbursement.
- An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.
Travel Required: Experience and Education Requirements: • Typically requires a Bachelor's degree in a technical discipline, and a minimum of 8-12 years related experience or Master's degree and 5-7 years equivalent industry experience or a PhD and 2-4 years of experience.
Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Salary:
$111,100.00 - $185,100.00
