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Auditor, Quality

4 months ago

Sunnyvale, California, United States Amazon Full time

Amazon Lab126 is an inventive research and development company that designs and engineers high-profile consumer electronics. Lab126 began in 2004 as a subsidiary of , Inc., originally creating the best-selling Kindle family of products. Since then, we have produced groundbreaking devices like Fire tablets, Fire TV, Amazon Echo and Amazon Show. The Amazon Devices group delivers delightfully unique Amazon experiences, giving customers instant access to everything, digital or physical.

Key job responsibilities

As a Quality Auditors on behalf of Amazon Devices and Services, your role is to help ensure all aspects of product quality meet regulatory requirement, applicable industry certifications, and internal expectations. This includes, but is not limited to, inspections of internal processes, suppliers, electronic manufacturing services, medical devices developed by Amazon and their operations, and M&A business.

As an auditor, you need to quickly acquire understanding of specific departments, operations and risks that can adversely impact Amazon business, customers. This program provides executive leadership with objective view of the health of the quality management systems, products and processes.

As an Auditor, you will use your work experience, in consumer electronics and medical devices development and manufacturing, to conduct and/or lead audits per regulatory requirements, industry standards, and Amazon Devices and Services expectations. Your role is to capture actionable insights that promote continuous improvement of product quality processes and operations. For the audits you conduct, you are responsible for all phases of the audit, including preparation, planning, conducting audits, reporting, and driving corrective actions and preventative actions to resolution. For the audit program, you will support its continuous improvement initiatives and help ensure the program meets business expectations.

A day in the life

The audit process investigates all aspects of Amazon Devices and Services product development life-cycle covering hardware and software development, together with support functions, including: manufacturing operations, program management, supply chain, materials management, quality engineering, supplier quality, logistics, and etc. External to Amazon, you may work with electronic contract manufacturers, regulators, and registration bodies as needed to support compliance, and certification.

About the team

The Quality Audit Program is part of Amazon Devices and Services' Quality & AME Department. As auditors, we work backwards from the customer to ensure Amazon provides a excellent customer experiences with our device products. We dive deep to inspect both internal operations, and external contract manufacturers processes for both medical and consumer electronics devices. Our mission is to educate, identify business and product quality risks, and review compliance with applicable regulatory requirements. We advocate continuous improvement, and diligently track findings to sustainable closure.

We are open to hiring candidates to work out of one of the following locations:

Sunnyvale, CA, USA

Basic Qualifications

  • 3+ years of program or project management experience
  • Experience using data and metrics to determine and drive improvements
  • Experience working cross functionally with tech and non-tech teams
  • Certified Lead Quality Auditor for ISO 9001 and ISO 13485 current standards
  • 3+ years work experience involving auditing of consumer electronics or medical devices (specifically: 21 CFR 820, 21 CFR Part 11, 21 CFR 803 and 806, clinical trials or other FDA regulations)
  • Excellent written and verbal communications skills
  • Bachelor's degree Mechanical Engineering, or another STEM field

Preferred Qualifications

  • Master's degree
  • Prior experience as a quality auditor of factory operations
  • 3+ years developing and executing Audit Plans (in a cross functional organizations), conducting Quality Audits (internally and supplier), writing Audit Reports and verifying effectiveness of the Corrective Actions
  • 3+ year experience preparing audit executive summaries and presenting results to C-Suite executives
  • Excellent organization skills with ability to prioritize and manage to critical project timelines in a fast-paced environment
  • Prior experience as quality management systems auditor in medical device industry
  • Prior experience as corporate QMS internal auditor
  • Six Sigma Green Belt

Amazon is committed to a diverse and inclusive workplace. Amazon is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. For individuals with disabilities who would like to request an accommodation, please visit

Our compensation reflects the cost of labor across several US geographic markets. The base pay for this position ranges from $66,800/year in our lowest geographic market up to $142,800/year in our highest geographic market. Pay is based on a number of factors including market location and may vary depending on job-related knowledge, skills, and experience. Amazon is a total compensation company. Dependent on the position offered, equity, sign-on payments, and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, financial, and/or other benefits. For more information, please visit This position will remain posted until filled. Applicants should apply via our internal or external career site.